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

FDA 510(k) Cleared Instruments, Surgical, Cardiovascular Devices (Product Code DWS)

71 devices
1–24 of 71
Cleared Oct 09, 2002
MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
K022238
Medtronic Vascular
Cardiovascular · 90d
Cleared Jan 30, 1997
OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)
K964445
Dlp, Inc.
Cardiovascular · 85d
Cleared Nov 19, 1996
BURKE CONGENITAL THORACOSCOPY INSTRUMENTS
K962771
Pilling Weck, Inc.
Cardiovascular · 126d
Cleared May 15, 1996
RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY
K955689
Contour Fabricators of Florida, Inc.
Cardiovascular · 153d
Cleared Apr 19, 1996
G.E. STERILE ANGIOGRAPHIC TRAY
K960139
GE Medical Systems
Cardiovascular · 94d
Cleared Apr 15, 1996
G.E. STERILE CT BIOPSY TRAY
K960144
GE Medical Systems
Cardiovascular · 90d
Cleared Apr 09, 1996
G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY
K960143
GE Medical Systems
Cardiovascular · 84d
Cleared Jan 10, 1994
REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER
K934727
Cardiac Pacemakers, Inc.
Cardiovascular · 101d
Cleared Mar 19, 1990
HYCULT DIAMOND CORONARY BYPASS KNIFE
K900379
St. Jude Medical, Inc.
Cardiovascular · 52d
Cleared Jan 19, 1990
INSULATION PAD
K896307
Bio-Vascular, Inc.
Cardiovascular · 80d
Cleared Sep 13, 1989
MODEL 6888 LEAD TUNNELER
K894738
Cardiac Pacemakers, Inc.
Cardiovascular · 48d
Cleared Jul 14, 1989
MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT
K893436
Pioneering Technologies, Inc.
Cardiovascular · 72d
Cleared May 19, 1989
MODIFIED EXTERNAL PAD
K891000
Instromedix, Inc.
Cardiovascular · 81d
Cleared Apr 13, 1989
DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM)
K890432
Deknatel, Inc.
Cardiovascular · 76d
Cleared Apr 10, 1989
PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL
K890707
Dlp, Inc.
Cardiovascular · 59d
Cleared Sep 27, 1988
PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP
K882981
Pioneering Technologies, Inc.
Cardiovascular · 74d
Cleared Sep 26, 1988
PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE)
K883135
Pioneering Technologies, Inc.
Cardiovascular · 62d
Cleared Jul 26, 1988
UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE
K881796
Universal Medical Instrument Corp.
Cardiovascular · 90d
Cleared Jul 05, 1988
PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE)
K881717
Buckman Co., Inc.
Cardiovascular · 75d
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

About Product Code DWS - Regulatory Context