FJS · Class II · 21 CFR 876.5630

FDA Product Code FJS: Catheter, Peritoneal, Long-term Indwelling

Leading manufacturers include Quinton, Inc., Accurate Surgical Instruments Co. and Medigroup, Inc..

48
Total
48
Cleared
139d
Avg days
1977
Since
48 devices
25–48 of 48
Cleared Oct 22, 1990
LIFECOIL CATHETER
K903502
Lifemed of California
Gastroenterology & Urology · 80d
Cleared Jul 27, 1990
PERITONEAL CATHETERS
K902101
Akcess Medical Products, Inc.
Gastroenterology & Urology · 80d
Cleared Mar 27, 1989
PERITONEAL CATHETERS WITH AN ADDED FUNCTION
K890288
Quinton, Inc.
Gastroenterology & Urology · 67d
Cleared Jan 31, 1989
TRUDELL BENT CATHETER
K885167
Sil-Med Corp.
Gastroenterology & Urology · 49d
Cleared Jul 16, 1987
VAS-CATH PERITONEAL DIALYSIS CATHETER
K871817
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 66d
Cleared Feb 04, 1987
CHEMO-CATH INTRAPERITONEAL CATHETER
K863819
Hdc Corp.
Gastroenterology & Urology · 127d
Cleared Sep 09, 1986
PERITONEAL DIALYSIS CATHETERS
K863128
Thermedics, Inc.
Gastroenterology & Urology · 25d
Cleared Jun 19, 1986
SWAN-NECK PERITONEAL DIALYSIS CATHETERS
K862046
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 21d
Cleared Dec 19, 1985
LONG TERM PERITONEAL CATHETER
K854614
Thermadics, Inc.
Gastroenterology & Urology · 31d
Cleared Jul 26, 1985
STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN
K850214
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 185d
Cleared May 21, 1982
GORE-TEX PERITONEAL CATHETERR
K820909
W.L. Gore & Associates, Inc.
Gastroenterology & Urology · 50d
Cleared Dec 31, 1981
CATHETER REGULAR
K813488
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 30d
Cleared Oct 19, 1981
CUFF MATERIAL ON PEDIATRIC SIZE CATH.
K812718
Quinton, Inc.
Gastroenterology & Urology · 24d
Cleared Oct 02, 1981
TENCKHOFF PERITONEAL CATHETERS
K812607
Quinton, Inc.
Gastroenterology & Urology · 17d
Cleared Mar 13, 1981
MIROMED PERITONEAL DIALYSIS CATHETER
K810236
American Medical Products, Inc.
Gastroenterology & Urology · 45d
Cleared Oct 23, 1980
TENCKHOFF CATHETER
K801818
Sil-Med Corp.
Gastroenterology & Urology · 84d
Cleared Oct 03, 1980
BETA-CAP II
K801679
Quinton, Inc.
Gastroenterology & Urology · 73d
Cleared Feb 27, 1979
CATHETER, RADIOPAQUE TENCKHOFF
K782057
Dravon Medical, Inc.
Gastroenterology & Urology · 82d
Cleared Feb 27, 1979
CATHETER, BETA-CAP-PERITONEAL
K782058
Dravon Medical, Inc.
Gastroenterology & Urology · 82d
Cleared May 16, 1978
BETA CAP SYSTEM
K780449
Quinton, Inc.
Gastroenterology & Urology · 57d
Cleared Apr 27, 1978
SHADOW-CATHS
K780643
Quinton, Inc.
Gastroenterology & Urology · 10d
Cleared Nov 28, 1977
BETA-CAP
K771420
Quinton, Inc.
Gastroenterology & Urology · 119d
Cleared Nov 28, 1977
CATHETER FINGER GRIP
K771483
Quinton, Inc.
Gastroenterology & Urology · 116d
Cleared Nov 28, 1977
PERITONEAL DIALYSIS CATHETER
K771555
Fluoro-Mold Co.
Gastroenterology & Urology · 108d