Cook Incorporated - FDA 510(k) Cleared Devices
175
Total
153
Cleared
1
Denied
69 devices
Cleared
May 19, 2016
Nester Embolization Coils, Tornado Embolization Coils
Cardiovascular
140d
Cleared
Mar 07, 2016
Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
Cardiovascular
103d
Cleared
Dec 18, 2015
MReye Embolization Coils
Cardiovascular
256d
Cleared
Dec 18, 2015
MReye Flipper Detachable Embolization Coil and Delivery System
Cardiovascular
252d
Cleared
Aug 14, 2015
Flexor Radial Hydrophilic Introducer Access Set
Cardiovascular
22d
Cleared
Jul 28, 2015
Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification
Cardiovascular
301d
Cleared
Jul 24, 2015
Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set
Cardiovascular
298d
Cleared
Jul 22, 2015
Retracta Detachable Embolization Coil
Cardiovascular
30d
Cleared
May 28, 2015
Heavy Double Flexible Tipped Wire Guide
Cardiovascular
63d
Cleared
May 12, 2015
Coda LP Balloon Catheter
Cardiovascular
29d
Cleared
Mar 27, 2015
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
Cardiovascular
311d
Cleared
Jul 03, 2014
MICROPUNCTURE INTRODUCER SET
Cardiovascular
276d
Cleared
Feb 14, 2013
EQUAFLOW MULTIVALVE INFUSION CATHETER
Cardiovascular
121d
Cleared
Jan 03, 2013
RETRACTA DETACHABLE EMBOLIZATION COIL
Cardiovascular
30d
Cleared
Jul 25, 2011
CXI TRIFORCE
Cardiovascular
82d
Cleared
Feb 25, 2011
APPROACH PRO ST WIRE GUIDE
Cardiovascular
37d
Cleared
Aug 08, 2008
APPROACH CTO WIRE GUIDE
Cardiovascular
87d
Cleared
Feb 27, 2008
VENA CAVA FILTER
Cardiovascular
72d
Cleared
Mar 06, 2006
MODIFICATION TO MIRA-FLEX 18 MICROCATHETER
Cardiovascular
35d