The U.S. Food and Drug Administration (FDA) must approve all medical devices before they can be marketed. A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).

February 9, 2007 - The FDA has released the 510(k)s Final Decisions Rendered for December 2006. There were none related to dialysis.

February 9, 2007 - The FDA has released the 510(k)s Final Decisions Rendered for November 2006. There are two related to dialysis:

DEVICE: 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND S
KENDALL
510(k) NO: K062671(SPECIAL)
ATTN: KEITH MARTIN
PHONE NO : 508-261-8440
15 HAMPSHIRE ST.
MANSFIELD, MA 02048
SE DECISION MADE: 03-NOV-06
510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROCKWELL MEDICAL TECHNOLOGIES, INC. CITRAPURE
ROCKWELL MEDICAL TECHNOLOGIES, INC
510(k) NO: K062399(TRADITIONAL)
ATTN: ROB CHIOINI
PHONE NO : 248-960-9009
30142 WIXOM RD.
SE DECISION MADE: 17-NOV-06
WIXOM, MI 48393
510(k) SUMMARY AVAILABLE FROM FDA

November 7, 2006 - The FDA has released the 510(k)s Final Decisions Rendered for October 2006. There are several related to dialysis:

DEVICE: XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
BAXTER HEALTHCARE CORPORATION
510(k) NO: K062079(TRADITIONAL)
ATTN: DAVID E CURTIN
PHONE NO : 847-785-6079
1620 WAUKEGAN ROAD
MCGAW PARK, IL 60085
SE DECISION MADE: 19-OCT-06
510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRISMA SYSTEM R03.10A
GAMBRO RENAL PRODUCTS
510(k) NO: K062090(TRADITIONAL)
ATTN: THOMAS B DOWELL
PHONE NO : 303-231-4094
10810 W. COLLINS AVE.
LAKEWOOD, CO 80215
SE DECISION MADE: 18-OCT-06
510(k) SUMMARY AVAILABLE FROM FDA

October 6, 2006 - The FDA has released the 510(k)s Final Decisions Rendered for September 2006. There are several related to dialysis:

DEVICE: RENALSOFT
BAXTER HEALTHCARE CORP.
510(k) NO: K061515(TRADITIONAL)
ATTN: DAVID E CURTIN
PHONE NO : 847-473-6079
1620 WAUKEGAN RD
SE DECISION MADE: 11-SEP-06
MCGAW PARK, IL 60085
510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION
DIALYSIS SERVICES, INC.
510(k) NO: K060333(TRADITIONAL)
ATTN: MIKE STERLING
PHONE NO : 615-384-4810
130 ELDER DR.
SE DECISION MADE: 08-SEP-06
SPRINGFIELD, TN 37172
510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS
SPIRE BIOMEDICAL, INC.
510(k) NO: K060288(TRADITIONAL)
ATTN: DONALD FICKETT
PHONE NO : 781-275-6001
ONE PATRIOTS PARK
SE DECISION MADE: 01-SEP-06
BEDFORD, MA 01730-2396
510(k) SUMMARY AVAILABLE FROM FDA

September 22, 2006 - The FDA has released the 510(k)s Final Decisions Rendered for August 2006. There is one related to dialysis:

DEVICE: KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATE
KENDALL
510(k) NO: K060972(TRADITIONAL)
ATTN: KEITH MARTIN
PHONE NO : 508-261-8440
15 HAMPSHIRE ST.
SE DECISION MADE: 04-AUG-06
MANSFIELD, MA 02048
510(k) SUMMARY AVAILABLE FROM FDA

August 11, 2006 - The FDA has released the 510(k)s Final Decisions Rendered for July 2006. There are several related to dialysis:

DEVICE: WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
BOB J. JOHNSON & ASSOCIATES
510(k) NO: K060942(TRADITIONAL)
ATTN: JON HULSEY
PHONE NO : 281-873-5555
16420 W. HARDY RD., STE. 100
SE DECISION MADE: 07-JUL-06
HOUSTON, TX 77060
510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORAL BALANCE LIQUID/ GEL
LACLEDE, INC.
510(k) NO: K061331(TRADITIONAL)
ATTN: MICHAEL A PELLICO
PHONE NO : 310-605-4280
2103 EAST UNIVERSITY DR.
SE DECISION MADE: 25-JUL-06
RANCHO DOMINQUEZ, CA 90220
510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NXSTAGE CARTRIDGE EXPRESS
NXSTAGE MEDICAL, INC.
510(k) NO: K061837(SPECIAL)
ATTN: NORMA LEMAY
PHONE NO : 978-687-4700
439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 31-JUL-06
LAWRENCE, MA 01843
510(k) SUMMARY AVAILABLE FROM FDA

Augst 11, 2006 - The FDA has released the 510(k)s Final Decisions Rendered for June 2006. There are several related to dialysis:
DEVICE: DIACAP ULTRA DIALYSIS FLUID FILTER
B. BRAUN MEDIZINTECHNOLOGIE GMBH 510(k) NO: K052764(TRADITIONAL)
ATTN: SCOTT J PEASE
PHONE NO : 610-266-0500
901 MARCON BOULEVARD
SE DECISION MADE: 09-JUN-06
ALLENTOWN, PA 18109-9341
510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HE
TYCO HEALTHCARE GROUP
510(k) NO: K060509(TRADITIONAL)
ATTN: KEITH MARTIN
PHONE NO : 508-261-8440
15 HAMPSHIRE ST.
SE DECISION MADE: 23-JUN-06
MANSFIELD, MA 02048
510(k) SUMMARY AVAILABLE FROM FDA


June 8, 2006 - The FDA has released the 510(k)s Final Decisions Rendered for May 2006. There are several related to dialysis:


DEVICE: MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
BAXTER HEALTHCARE CORPORATION
510(k) NO: K053539(TRADITIONAL)
ATTN: DAVID E CURTIN
PHONE NO : 847-473-6079
1620 WAUKEGAN ROAD
SE DECISION MADE: 24-MAY-06
MCGAW PARK, IL 60085
510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100
RENAL SOLUTIONS, INC.
510(k) NO: K060381(SPECIAL)
ATTN: DAVID J VANELLA
PHONE NO : 724-772-6900
770 COMMONWEALTH DR.
SE DECISION MADE: 24-MAY-06
WARRENDALE, PA 15086
510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER
SPIRE BIOMEDICAL, INC.
510(k) NO: K060155(TRADITIONAL)
ATTN: DONALD FICKETT
PHONE NO : 781-275-6001
ONE PATRIOTS PARK
SE DECISION MADE: 09-MAY-06
BEDFORD, MA 01730-2396
510(k) SUMMARY AVAILABLE FROM FDA



May 8, 2006 - The FDA has released the 510(k)s Final Decisions Rendered for April 2006. There are two related to dialysis:

DEVICE: LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING
BARD ACCESS SYSTEMS, INC.
510(k) NO: K053589(TRADITIONAL)
ATTN: MICHAELA RIVKOWICH
PHONE NO : 801-595-0700
5425 WEST AMELIA EARNHART DR.
SE DECISION MADE: 13-APR-06
SALT LAKE CITY, UT 84116
510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE
GAMBRO RENAL PRODUCTS
510(k) NO: K060195(TRADITIONAL)
ATTN: THOMAS B DOWELL
PHONE NO : 303-231-4094
10810 WEST COLLINS AVE.
SE DECISION MADE: 24-APR-06
LAKEWOOD, CO 80215
510(k) SUMMARY AVAILABLE FROM FDA



April 7, 2006 - The FDA has released the 510(k)s Final Decisions Rendered for March 2006. There are three related to dialysis:
DEVICE: NXSTAGE DIALYSATE PREPARATION MODULE
NXSTAGE MEDICAL, INC.
510(k) NO: K060296(SPECIAL)
ATTN: NORMA LEMAY
PHONE NO : 978-687-4746
439 SOUTH UNION ST.
SE DECISION MADE: 31-MAR-06
SUITE 501
510(k) SUMMARY AVAILABLE FROM FDA
LAWRENCE, MA 01843

DEVICE: MODIFICATION TO WHOLE PTH (1-84)SPECIFIC IMMUNOCHEMILLUMINOMETR
SCANTIBODIES LABORATORY, INC.
510(k) NO: K060420(SPECIAL)
ATTN: MICHAEL NORDSTROM
PHONE NO : 619-258-9300
9336 ABRAHAM WAY
SE DECISION MADE: 01-MAR-06
SANTEE, CA 92071
510(k) STATEMENT



March 7, 2006 - The FDA has released the 510(k)s Final Decisions Rendered for February 2006. There are three related to dialysis:
DEVICE: HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SY

BAXTER HEALTHCARE CORP.
510(k) NO: K053512(TRADITIONAL)
ATTN: DAVID E CURTIN
PHONE NO : 847-473-6079
1620 WAUKEGAN RD
SE DECISION MADE: 16-FEB-06
MCGAW PARK, IL 60085
510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA)
SCANTIBODIES LABORATORY, INC.
510(k) NO: K060348(SPECIAL)
ATTN: MICHAEL NORDSTROM
PHONE NO : 619-258-9300
9336 ABRAHAM WAY
SE DECISION MADE: 27-FEB-06
SANTEE, CA 92071
510(k) SUMMARY AVAILABLE FROM FDA



February 9, 2006 - The FDA has released the 510(k)s Final Decisions Rendered for January 2006. There are three related to dialysis:
DEVICE: AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
AMERIWATER
510(k) NO: K051031 (TRADITIONAL)
ATTN: BRIAN R BOWMAN
PHONE NO : 937-461-8833
1257 STANLEY AVE.
SE DECISION MADE: 06-JAN-06
DAYTON, OH 45404
510(k) SUMMARY AVAILABLE FROM FDA

This message has been edited. Last edited by: Gary Peterson,