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
190 devices
76-100 of 190
Cleared Jul 11, 2003
COOK GASTRIC SIZING BALLOON CATHETER
K030841 · KNT
Gastroenterology & Urology · 116d
Cleared Jun 26, 2003
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K031766 · DQY
Cardiovascular · 17d
Cleared May 30, 2003
SPECTRUM SILICONE CATHETER
K021557 · FOZ
General Hospital · 382d
Cleared Nov 13, 2002
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K023504 · LIT
Cardiovascular · 26d
Cleared Sep 27, 2002
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K022552 · DQY
Cardiovascular · 56d
Cleared Aug 14, 2002
7.0 FR. ENDOBRONCHIAL BLOCKER
K021920 · CBI
Anesthesiology · 64d
Cleared Jul 01, 2002
TRIPLE LUMEN CENTRAL VENOUS CATHETER
K013182 · FOZ
General Hospital · 280d
Cleared Apr 22, 2002
TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
K013865 · CBI
Anesthesiology · 152d
Cleared Feb 21, 2002
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
K013241 · BWC
Anesthesiology · 146d
Cleared Feb 21, 2002
PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET
K013252 · BWC
Anesthesiology · 146d
Cleared Dec 20, 2001
MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
K013916 · BWC
Anesthesiology · 23d
Cleared Nov 16, 2001
FANELLI BILIARY STENT
K010601 · FGE
Gastroenterology & Urology · 261d
Cleared Nov 08, 2001
SPECTRUM VENTRICULAR CATHETER
K011812 · NHC
Neurology · 150d
Cleared Oct 09, 2001
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
K010016 · BWC
Anesthesiology · 280d
Cleared Sep 06, 2001
LIVER TAMPONADE BALLOON
K010450 · NGU
General & Plastic Surgery · 203d
Cleared Aug 13, 2001
COOK ZILVER BILIARY STENT
K010242 · FGE
Gastroenterology & Urology · 200d
Cleared Mar 22, 2001
LDOB OCCLUSION BALLOON CATHETER
K002286 · MJN
Cardiovascular · 238d
Cleared Mar 16, 2001
COOK PRESSURE MONITORING CATHETER
K002254 · DQO
Cardiovascular · 234d
Cleared Jan 25, 2001
INTRODEUCE DOUBLE LUMEN INTRODUCER
K001985 · DYB
Cardiovascular · 210d
Cleared Jan 24, 2001
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
K010034 · FOZ
General Hospital · 20d
Cleared Nov 28, 2000
ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
K002288 · CBI
Anesthesiology · 124d
Cleared Nov 24, 2000
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
K000651 · HCG
Neurology · 270d
Cleared Oct 18, 2000
GUNTHER TULIP VENA CAVA MREYE FILTER SET
K000855 · DTK
Cardiovascular · 216d
Cleared Jul 20, 2000
PTA BALLOON CATHETER
K001087 · LIT
Cardiovascular · 107d
Cleared Jan 11, 2000
FLIPPER DETACHABLE EMBOLIZATION COIL
K993455 · KRD
Cardiovascular · 90d

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