Cook, Inc. - FDA 510(k) Cleared Devices
190
Total
179
Cleared
0
Denied
190 devices
Cleared
Dec 20, 1999
EMBOLIZATION COIL SYSTEM
Cardiovascular
180d
Cleared
Aug 27, 1999
URETHANE PICC LINE MODEL UPICS-
General Hospital
58d
Cleared
Aug 20, 1999
COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET
General Hospital
67d
Cleared
May 27, 1999
GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
Radiology
80d
Cleared
Apr 02, 1999
ENVY GUIDING CATHETER
Cardiovascular
28d
Cleared
Feb 12, 1999
MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY
Gastroenterology & Urology
225d
Cleared
Jan 27, 1999
CHAIT CECOSTOMY CATHETER
Gastroenterology & Urology
191d
Cleared
Jan 20, 1999
ROWE DUAL-CHECK VALVE
General Hospital
128d
Cleared
Nov 12, 1998
STRATEGY CORONARY WIRE GUIDE
Cardiovascular
17d
Cleared
Nov 03, 1998
VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
Radiology
158d
Cleared
Oct 16, 1998
ENVY GUIDING CATHETER
Cardiovascular
298d
Cleared
Aug 20, 1998
PTA BALLOON CATHETER
Cardiovascular
199d
Cleared
Jun 29, 1998
MODIFICATION FOR PTA BALLOON CATHETER
Cardiovascular
28d
Cleared
Apr 16, 1998
PTA BALLOON CATHETER
Cardiovascular
262d
Cleared
Nov 03, 1997
QUICK-CARE BIOPSY NEEDLE
Gastroenterology & Urology
45d
Cleared
Aug 29, 1997
BRONCHIAL BLOCKER
Anesthesiology
450d
Cleared
Jul 14, 1997
MRI NEEDLES
Gastroenterology & Urology
312d
Cleared
Nov 04, 1996
MICROFERRET CATHETER
Cardiovascular
188d
Cleared
Oct 11, 1996
REIGEL TUNNELING DEVICE
Neurology
87d
Cleared
Aug 29, 1996
VENTRICULAR CATHETER SET
Neurology
92d
Cleared
Feb 08, 1996
ABRM CATHETER
General Hospital
393d
Cleared
Sep 29, 1995
MULLAN GANGLION MICROCOMPRESSION SET
Neurology
575d
Cleared
Jan 04, 1995
COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT
Gastroenterology & Urology
71d
Cleared
Nov 28, 1994
COIL POSITIONER SET
Cardiovascular
319d
Cleared
Oct 14, 1994
ARTERIAL EMBOLIZATION DEVICE (KRD)
Cardiovascular
227d
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