Medical Device Manufacturer · US , Mchenry , IL

Cook, Inc.

190 submissions · 179 cleared · Since 1976
190
Total
179
Cleared
0
Denied

Cook, Inc. — FDA 510(k) Submissions

Cook, Inc. has submitted 190 FDA 510(k) premarket notifications since 1976, of which 179 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Percutaneous, Stents, Drains And Dilators For The Biliary Ducts, Catheter, Angioplasty, Peripheral, Transluminal, Wire, Guide, Catheter, Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days . Use the specialty filter in the sidebar to narrow results.

190 devices
1–12 of 190
BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
K133130 · DQO Catheter, Intravascular,... · Cardiovascular
Jan 2015 466d
ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
K140593 · GCJ Laparoscope, General &... · General & Plastic Surgery
Dec 2014 283d
FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
K132592 · DYB Introducer, Catheter · Cardiovascular
Oct 2014 416d
CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
K133597 · JOH Tube Tracheostomy And... · Anesthesiology
Apr 2014 147d
CANTATA(R) 2.9 MICROCATHETER
K131772 · KRA Catheter, Continuous Flush · Cardiovascular
Feb 2014 248d
ADVANCE CS CORONARY SINUS INFUSION CATHETER
K131204 · DQY Catheter, Percutaneous · Cardiovascular
Jan 2014 275d
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
K133634 · LJS Catheter, Intravascular,... · General Hospital
Dec 2013 27d
ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K132020 · LIT Catheter, Angioplasty,... · Cardiovascular
Oct 2013 116d
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
K131201 · FGE Stents, Drains And... · Gastroenterology & Urology
Oct 2013 161d
COOK CERVICAL RIPENING BALLOON
K131206 · PFJ Catheter, Balloon,... · Obstetrics & Gynecology
Sep 2013 151d
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
K132334 · LJS Catheter, Intravascular,... · General Hospital
Aug 2013 21d
COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY
K122091 · MPB Catheter, Hemodialysis,... · Gastroenterology & Urology
Jul 2013 378d

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