Cook Incorporated - FDA 510(k) Cleared Devices
175
Total
153
Cleared
1
Denied
69 devices
Cleared
Mar 09, 2018
Transjugular Liver Access Sets
Cardiovascular
263d
Cleared
Jan 25, 2018
Royal Flush Catheter
Cardiovascular
269d
Cleared
Jan 10, 2018
Amplatz Support Wire Guide with Apex Curve
Cardiovascular
239d
Cleared
Jan 05, 2018
Roadrunner Extra Support Wire Guide
Cardiovascular
190d
Cleared
Dec 20, 2017
Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus...
Cardiovascular
233d
Cleared
Dec 20, 2017
Peel-Away Introducer Set
Cardiovascular
19d
Cleared
Nov 17, 2017
Performer Introducer
Cardiovascular
49d
Cleared
Nov 15, 2017
Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and...
Cardiovascular
30d
Cleared
Nov 13, 2017
CXI TriForce Peripheral Crossing Set
Cardiovascular
229d
Cleared
Oct 18, 2017
Liberator Beacon Tip Locking Stylet
Cardiovascular
260d
Cleared
Sep 28, 2017
Peel-Away Introducer Set
Cardiovascular
268d
Cleared
Aug 24, 2017
Liver Access and Biopsy Sets
Cardiovascular
64d
Cleared
Aug 21, 2017
Approach CTO Microwire Guide
Cardiovascular
56d
Cleared
Jul 31, 2017
Performer Introducer
Cardiovascular
28d
Cleared
Jul 27, 2017
Bunegin-Albin Air Aspiration Set
Cardiovascular
269d
Cleared
Jul 11, 2017
Needle's Eye Snare Retrieval Set - 54cm
Cardiovascular
223d
Cleared
May 26, 2017
White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing...
Cardiovascular
267d
Cleared
Apr 28, 2017
van Andel Dilatation Catheter
Cardiovascular
58d
Cleared
Feb 13, 2017
Advance 14LP Low Profile PTA Balloon Dilatation Catheter
Cardiovascular
21d
Cleared
Nov 22, 2016
CXI Support Catheter
Cardiovascular
236d
Cleared
Oct 27, 2016
Torcon NB Advantage Catheters
Cardiovascular
118d
Cleared
Sep 02, 2016
Indy OTW Vascular Retriever
Cardiovascular
185d
Cleared
Aug 03, 2016
Hilal Embolization MicroCoils
Cardiovascular
187d
Cleared
Jul 29, 2016
CrossCath Support Catheter
Cardiovascular
29d
Cleared
Jul 22, 2016
Gianturco-Roehm Bird’s Nest Vena Cava Filter
Cardiovascular
84d