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

FDA 510(k) Regulatory Record - Cook, Inc. General Hospital ✕

22 devices

1-12 of 22

Cleared Dec 23, 2013

SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

General Hospital · 27d

Cleared Aug 16, 2013

TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET

General Hospital · 21d

Cleared Jun 14, 2011

TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)

General Hospital · 42d

Cleared Jul 30, 2008

COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS

General Hospital · 103d

Cleared Jul 14, 2008

SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

General Hospital · 27d

Cleared Dec 13, 2007

TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)

General Hospital · 87d

Cleared Feb 17, 2006

SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM

General Hospital · 25d

Cleared Jul 21, 2005

General Hospital · 378d

Cleared Aug 12, 2004

SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING

General Hospital · 246d

Cleared Feb 26, 2004

COOK FIVE LUMEN CENTRAL VENOUS CATHETER

General Hospital · 218d

Cleared May 30, 2003

SPECTRUM SILICONE CATHETER

General Hospital · 382d

Cleared Jul 01, 2002

TRIPLE LUMEN CENTRAL VENOUS CATHETER

General Hospital · 280d