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
26-50 of 81
Cleared Nov 09, 2007
CXI SUPPORT CATHETER
K072724 · KRA
Cardiovascular · 44d
Cleared Nov 08, 2007
GUNTHER TULIP VENA CAVA FILTER
K072240 · DTK
Cardiovascular · 87d
Cleared Apr 27, 2007
COOK MICROWIRE WIRE GUIDE
K070410 · DQX
Cardiovascular · 74d
Cleared Dec 20, 2006
FLIPPER DETACHABLE EMBOLIZATION COILS
K063619 · KRD
Cardiovascular · 15d
Cleared Nov 14, 2006
ATB ADVANCED PTA DILATATION CATHETER
K063252 · DQY
Cardiovascular · 18d
Cleared Dec 08, 2005
MIRA-FLEX 18 MICROCATHETER
K052841 · KRA
Cardiovascular · 62d
Cleared Nov 23, 2005
MREYE EMBOLIZATION COIL
K052834 · KRD
Cardiovascular · 48d
Cleared Aug 25, 2005
ATB ADVANCE PTA DILATATION CATHETER
K052036 · DQY
Cardiovascular · 28d
Cleared May 05, 2005
GUNTHER TULIP VENA CAVA FILTER SET
K043509 · DTK
Cardiovascular · 136d
Cleared Nov 12, 2004
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
K042611 · DQX
Cardiovascular · 49d
Cleared Apr 02, 2004
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K033875 · DQY
Cardiovascular · 109d
Cleared Nov 19, 2003
COOK CODA BALLOON CATHETER
K032869 · DQY
Cardiovascular · 65d
Cleared Oct 31, 2003
GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
K032426 · DTK
Cardiovascular · 86d
Cleared Oct 22, 2003
PTA BALLOON CATHETER
K032931 · DQY
Cardiovascular · 30d
Cleared Jun 26, 2003
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K031766 · DQY
Cardiovascular · 17d
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 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 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
Cleared Dec 20, 1999
EMBOLIZATION COIL SYSTEM
K992121 · KRD
Cardiovascular · 180d
Cleared Apr 02, 1999
ENVY GUIDING CATHETER
K990726 · DQY
Cardiovascular · 28d

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