Medical Device Manufacturer · US , Mchenry , IL

Cook, Inc. - FDA 510(k) Cleared Devices

190 submissions · 179 cleared · Since 1976
190
Total
179
Cleared
0
Denied
81 devices
51-75 of 81
Cleared Nov 12, 1998
STRATEGY CORONARY WIRE GUIDE
K983771 · DQX
Cardiovascular · 17d
Cleared Oct 16, 1998
ENVY GUIDING CATHETER
K974774 · DQO
Cardiovascular · 298d
Cleared Aug 20, 1998
PTA BALLOON CATHETER
K980390 · LIT
Cardiovascular · 199d
Cleared Jun 29, 1998
MODIFICATION FOR PTA BALLOON CATHETER
K981906 · LIT
Cardiovascular · 28d
Cleared Apr 16, 1998
PTA BALLOON CATHETER
K972800 · LIT
Cardiovascular · 262d
Cleared Nov 04, 1996
MICROFERRET CATHETER
K961668 · KRA
Cardiovascular · 188d
Cleared Nov 28, 1994
COIL POSITIONER SET
K940189 · KRD
Cardiovascular · 319d
Cleared Oct 14, 1994
ARTERIAL EMBOLIZATION DEVICE (KRD)
K940982 · KRD
Cardiovascular · 227d
Cleared May 20, 1993
ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED
K924358 · LIT
Cardiovascular · 267d
Cleared Mar 04, 1993
WELTER SNARE RETRIEVER
K920823 · DXE
Cardiovascular · 374d
Cleared Dec 21, 1992
ROADRUNNER(TM) WIRE GUIDE, MODIFICATION
K920891 · DQX
Cardiovascular · 301d
Cleared Oct 16, 1992
ROADRUNNER RLTF GUIDE WIRE
K920824 · DQX
Cardiovascular · 235d
Cleared May 01, 1992
VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)
K914856 · DQY
Cardiovascular · 185d
Cleared Feb 22, 1991
ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER
K900677 · LIT
Cardiovascular · 375d
Cleared Feb 01, 1991
VASCULAR RETRIEVAL FORCEPS
K902999 · DQY
Cardiovascular · 207d
Cleared Sep 27, 1990
ROADRUNNER WIRE GUIDE
K901899 · DQX
Cardiovascular · 153d
Cleared Sep 04, 1990
COOK CORONARY GUIDING CATHETER
K902905 · DQY
Cardiovascular · 64d
Cleared Feb 26, 1990
DUAL GUIDE INTRODUCER CATHETER
K895044 · DYB
Cardiovascular · 201d
Cleared Dec 05, 1988
FLEXIBLE MYOCARDIAL BIOPSY FORCEPS
K883723 · DWZ
Cardiovascular · 96d
Cleared Sep 27, 1988
EXTRACORPOREAL MEMBRANE OXYGENATION CATHETER
K882771 · DWF
Cardiovascular · 83d
Cleared Sep 14, 1988
OMEGA NV(TM) BALLOON DILATATION CATHETER
K882052 · LIT
Cardiovascular · 121d
Cleared Aug 19, 1988
COATING FOR WIRE GUIDE
K880722 · DQX
Cardiovascular · 178d
Cleared Jul 28, 1988
SLIP-COAT(TM) CATHETERS
K882796 · DQO
Cardiovascular · 22d
Cleared Aug 12, 1987
DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)
K870215 · LIT
Cardiovascular · 204d
Cleared Oct 30, 1986
COOK (R) VEIN GRAFT RING MARKERS
K864101 · KPK
Cardiovascular · 9d

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