DWS · Class I · 21 CFR 870.4500

FDA Product Code DWS: Instruments, Surgical, Cardiovascular

Leading manufacturers include GE Medical Systems, Manan Manufacturing Co., Inc. and Pilling Co..

71
Total
71
Cleared
55d
Avg days
1976
Since
71 devices
25–48 of 71
Cleared Jul 11, 1985
MANAN GWI GUIDE WIRE INTRODUCER
K851834
Manan Manufacturing Co., Inc.
Cardiovascular · 76d
Cleared Jun 19, 1985
TELEFLEX MEDICAL INTRODUCER NEEDLE
K851140
Teleflexmedical, Inc.
Cardiovascular · 90d
Cleared Jan 24, 1985
GORE-TEX TUNNELER
K844584
W.L. Gore & Associates, Inc.
Cardiovascular · 62d
Cleared Jun 05, 1984
PMA ANGIOGRAPHY TRAY
K841468
Professional Medical Services
Cardiovascular · 57d
Cleared Apr 23, 1984
CATEGORY 1 CIRCULATORY SYSTEM DEVICE
K840305
Imm Enterprises , Ltd.
Cardiovascular · 90d
Cleared Jul 07, 1983
LEATHER VALVE CUTTER
K831455
American V. Mueller
Cardiovascular · 62d
Cleared Mar 24, 1983
SCANLAN SINGLE-USE AORTA PUNCH
K823764
Scanlan Intl., Inc.
Cardiovascular · 100d
Cleared May 27, 1982
LEATHER VALVULOTOME
K821569
American V. Mueller
Cardiovascular
Cleared Mar 02, 1982
DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH
K820258
Howmedica Corp.
Cardiovascular · 29d
Cleared Sep 16, 1980
DEKNATEL GOOSEN VASCULAR PUNCH BLADES
K802079
Howmedica Corp.
Cardiovascular · 19d
Cleared Jun 30, 1980
AIR ASPIRATOR NEEDLE
K801393
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Dec 19, 1979
CASTROVIEJO VASCULAR SCISSORS
K792576
Edward Weck, Inc.
Cardiovascular · 6d
Cleared Oct 26, 1979
AORTIC OCCLUDER #000390
K792088
Edward Weck, Inc.
Cardiovascular · 9d
Cleared Sep 12, 1979
CARDIOVASCULAR INSTRUMENTS-VARIOUS
K791710
Edward Weck, Inc.
Cardiovascular · 16d
Cleared Aug 03, 1979
SILICONE SURGICAL VESSEL LOOPS
K791370
Conphar, Inc.
Cardiovascular · 10d
Cleared Feb 08, 1979
GRAFT TUNNELER
K790124
Narco Scientific
Cardiovascular · 16d
Cleared Oct 10, 1978
SURGITEK DISPOSABLE FLO-RESTER
K781336
Medical Engineering Corp.
Cardiovascular · 68d
Cleared Apr 28, 1978
AORTIC PUMP
K780567
Ethicon, Inc.
Cardiovascular · 22d
Cleared Jun 20, 1977
HUANG VEIN HOLDER, #21-8011
K771026
Codman & Shurtleff, Inc.
Cardiovascular · 12d
Cleared Feb 01, 1977
ANASTOMASIS OCCLUDER
K761328
Medical Engineering Corp.
Cardiovascular · 36d
Cleared Dec 06, 1976
67-8006 DARLING-LINTON AORTIC TOURN.
K761161
Codman & Shurtleff, Inc.
Cardiovascular · 7d
Cleared Nov 11, 1976
COOLEY ANGLED SCISSOR - 1MM PROBE POINT
K760791
V. Mueller O.V. Baxter Healthcare Corp.
Cardiovascular · 35d
Cleared Nov 11, 1976
SCISSOR - 1.5MM PROBE POINT, ANGLED
K760792
V. Mueller O.V. Baxter Healthcare Corp.
Cardiovascular · 35d
Cleared Sep 21, 1976
CAROTID ARTERY ARTERIOTOMY CLOSURE CLAMP
K760645
Pilling Co.
Cardiovascular · 6d