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
1-22 of 22
Cleared Dec 23, 2013
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
K133634 · LJS
General Hospital · 27d
Cleared Aug 16, 2013
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
K132334 · LJS
General Hospital · 21d
Cleared Jun 14, 2011
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
K111244 · LJS
General Hospital · 42d
Cleared Jul 30, 2008
COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS
K081113 · FOZ
General Hospital · 103d
Cleared Jul 14, 2008
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
K081690 · FOZ
General Hospital · 27d
Cleared Dec 13, 2007
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
K072625 · LJS
General Hospital · 87d
Cleared Feb 17, 2006
SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM
K060174 · FOZ
General Hospital · 25d
Cleared Jul 21, 2005
TURBO-FLO PICC
K041849 · LJS
General Hospital · 378d
Cleared Aug 12, 2004
SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
K033843 · FOZ
General Hospital · 246d
Cleared Feb 26, 2004
COOK FIVE LUMEN CENTRAL VENOUS CATHETER
K032274 · FOZ
General Hospital · 218d
Cleared May 30, 2003
SPECTRUM SILICONE CATHETER
K021557 · FOZ
General Hospital · 382d
Cleared Jul 01, 2002
TRIPLE LUMEN CENTRAL VENOUS CATHETER
K013182 · FOZ
General Hospital · 280d
Cleared Jan 24, 2001
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
K010034 · FOZ
General Hospital · 20d
Cleared Aug 27, 1999
URETHANE PICC LINE MODEL UPICS-
K992198 · FOZ
General Hospital · 58d
Cleared Aug 20, 1999
COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET
K991985 · FPA
General Hospital · 67d
Cleared Jan 20, 1999
ROWE DUAL-CHECK VALVE
K983217 · FPA
General Hospital · 128d
Cleared Feb 08, 1996
ABRM CATHETER
K950118 · FOZ
General Hospital · 393d
Cleared Mar 04, 1992
DISPOSABLE INTROSSEOUS INFUSION NEEDLES
K913258 · FMI
General Hospital · 225d
Cleared Mar 04, 1992
INTRAOSSEOUS ACCESS NEEDLE
K915409 · FMI
General Hospital · 93d
Cleared Mar 14, 1986
GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION
K851243 · LJS
General Hospital · 381d
Cleared Nov 19, 1985
GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
K851244 · KDQ
General Hospital · 266d
Cleared Jun 15, 1979
WHOLEY OCCLUSION BALLOON CATHETER
K772011 · FOZ
General Hospital · 598d
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