DWS · Class I · 21 CFR 870.4500

FDA Product Code DWS: Instruments, Surgical, Cardiovascular

Leading manufacturers include Pioneering Technologies, Inc., Edward Weck, Inc. and Manan Manufacturing Co., Inc..

71
Total
71
Cleared
55d
Avg days
1976
Since
71 devices
25–48 of 71
Cleared Feb 05, 1988
CARDIOVASCULAR SURGICAL INSTRUMENTS
K874960
Solway, Inc.
Cardiovascular · 65d
Cleared Nov 24, 1986
MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY
K864461
Medsurg Industries, Inc.
Cardiovascular · 12d
Cleared May 13, 1986
VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET
K861745
Keeler Instruments, Inc.
Cardiovascular · 7d
Cleared Jul 12, 1985
SCANLAN TUNNELER, SHEATH & TIP
K851825
Scanlan Intl., Inc.
Cardiovascular · 77d
Cleared Jul 11, 1985
NAMAN POTTS COURNAND NEEDLE
K851832
Manan Manufacturing Co., Inc.
Cardiovascular · 76d
Cleared Jul 11, 1985
MANAN SELDINGER NEEDLE
K851833
Manan Manufacturing Co., Inc.
Cardiovascular · 76d
Cleared Jul 11, 1985
MANAN GWI GUIDE WIRE INTRODUCER
K851834
Manan Manufacturing Co., Inc.
Cardiovascular · 76d
Cleared Jun 24, 1985
MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR
K851152
Cryomedics, Inc.
Cardiovascular · 95d
Cleared Jun 19, 1985
TELEFLEX MEDICAL INTRODUCER NEEDLE
K851140
Teleflexmedical, Inc.
Cardiovascular · 90d
Cleared Apr 24, 1985
LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR
K850394
Vascutech, Inc.
Cardiovascular · 82d
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 Jan 26, 1984
ROTARY VASCULAR KNIFE
K833547
Formedco, Inc.
Cardiovascular · 106d
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 Mar 24, 1983
KELLY-WICK TANNELER
K830471
Intl. Medical Prosthetics Research
Cardiovascular · 37d
Cleared Dec 15, 1982
CARDIAC ELEVATOR
K823094
Cardio Surgical Research, Inc.
Cardiovascular · 56d
Cleared Nov 17, 1982
ROTARY VASCULAR KNIFE
K822829
Medco Products, Co., Inc.
Cardiovascular · 57d
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 Dec 29, 1981
VENOUS CANNULA TRAY
K813284
Cunningham Woodland, Inc.
Cardiovascular · 36d
Cleared Aug 31, 1981
NEOLOOPS
K810890
Medical Marketing Systems
Cardiovascular · 151d
Cleared Sep 16, 1980
DEKNATEL GOOSEN VASCULAR PUNCH BLADES
K802079
Howmedica Corp.
Cardiovascular · 19d