FDA 510(k) Applications Submitted by COOK, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K122937 |
09/24/2012 |
SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) |
COOK, INC. |
| K950118 |
01/11/1995 |
ABRM CATHETER |
COOK, INC. |
| K980390 |
02/02/1998 |
PTA BALLOON CATHETER |
COOK, INC. |
| K990726 |
03/05/1999 |
ENVY GUIDING CATHETER |
COOK, INC. |
| K990753 |
03/08/1999 |
GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER |
COOK, INC. |
| K961668 |
04/30/1996 |
MICROFERRET CATHETER |
COOK, INC. |
| K021557 |
05/13/2002 |
SPECTRUM SILICONE CATHETER |
COOK, INC. |
| K981886 |
05/29/1998 |
VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER |
COOK, INC. |
| K981906 |
06/01/1998 |
MODIFICATION FOR PTA BALLOON CATHETER |
COOK, INC. |
| K962167 |
06/05/1996 |
BRONCHIAL BLOCKER |
COOK, INC. |
| K011812 |
06/11/2001 |
SPECTRUM VENTRICULAR CATHETER |
COOK, INC. |
| K021920 |
06/11/2002 |
7.0 FR. ENDOBRONCHIAL BLOCKER |
COOK, INC. |
| K991985 |
06/14/1999 |
COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET |
COOK, INC. |
| K001985 |
06/29/2000 |
INTRODEUCE DOUBLE LUMEN INTRODUCER |
COOK, INC. |
| K982333 |
07/02/1998 |
MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY |
COOK, INC. |
| K962761 |
07/16/1996 |
REIGEL TUNNELING DEVICE |
COOK, INC. |
| K982500 |
07/20/1998 |
CHAIT CECOSTOMY CATHETER |
COOK, INC. |
| K002254 |
07/25/2000 |
COOK PRESSURE MONITORING CATHETER |
COOK, INC. |
| K002288 |
07/27/2000 |
ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER |
COOK, INC. |
| K972800 |
07/28/1997 |
PTA BALLOON CATHETER |
COOK, INC. |
| K963565 |
09/05/1996 |
MRI NEEDLES |
COOK, INC. |
| K983217 |
09/14/1998 |
ROWE DUAL-CHECK VALVE |
COOK, INC. |
| K973565 |
09/19/1997 |
QUICK-CARE BIOPSY NEEDLE |
COOK, INC. |
| K983771 |
10/26/1998 |
STRATEGY CORONARY WIRE GUIDE |
COOK, INC. |
| K974774 |
12/22/1997 |
ENVY GUIDING CATHETER |
COOK, INC. |
| K962097 |
05/29/1996 |
VENTRICULAR CATHETER SET |
COOK, INC. |
| K030841 |
03/17/2003 |
COOK GASTRIC SIZING BALLOON CATHETER |
COOK, INC. |
| K031821 |
06/13/2003 |
MODIFICATION TO COOK ZILVER BILIARY STENT |
COOK, INC. |
| K131206 |
04/29/2013 |
COOK CERVICAL RIPENING BALLOON |
COOK, INC. |
| K130766 |
03/20/2013 |
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE |
COOK, INC. |
| K132592 |
08/19/2013 |
FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET |
COOK, INC. |
| K123707 |
12/03/2012 |
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE |
COOK, INC. |
| K130293 |
02/06/2013 |
ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER |
COOK, INC. |
| K133130 |
09/30/2013 |
BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER |
COOK, INC. |
| K042611 |
09/24/2004 |
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE |
COOK, INC. |
| K041849 |
07/08/2004 |
TURBO-FLO PICC |
COOK, INC. |
| K043509 |
12/20/2004 |
GUNTHER TULIP VENA CAVA FILTER SET |
COOK, INC. |
| K122940 |
09/24/2012 |
ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3 |
COOK, INC. |
| K122917 |
09/25/2012 |
CODA BALLOON CATHETER |
COOK, INC. |
| K113300 |
11/09/2011 |
ATB ADVANCE PTA DILATATION CATHETER |
COOK, INC. |
| K131201 |
04/29/2013 |
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET |
COOK, INC. |
| K060174 |
01/23/2006 |
SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM |
COOK, INC. |
| K013241 |
09/28/2001 |
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET |
COOK, INC. |
| K013252 |
09/28/2001 |
PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET |
COOK, INC. |
| K013916 |
11/27/2001 |
MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET |
COOK, INC. |
| K041044 |
04/22/2004 |
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET |
COOK, INC. |
| K033843 |
12/10/2003 |
SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING |
COOK, INC. |
| K131204 |
04/29/2013 |
ADVANCE CS CORONARY SINUS INFUSION CATHETER |
COOK, INC. |
| K131772 |
06/17/2013 |
CANTATA(R) 2.9 MICROCATHETER |
COOK, INC. |
| K031966 |
06/26/2003 |
ENK FIBEROPTIC ATOMIZER SET |
COOK, INC. |
| K032274 |
07/23/2003 |
COOK FIVE LUMEN CENTRAL VENOUS CATHETER |
COOK, INC. |
| K032426 |
08/06/2003 |
GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET |
COOK, INC. |
| K042691 |
09/29/2004 |
VERTEFIX VERTEBROPLASTY PROCEDURE SET |
COOK, INC. |
| K110009 |
01/03/2011 |
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE |
COOK, INC. |
| K090133 |
01/21/2009 |
CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS |
COOK, INC. |
| K070410 |
02/12/2007 |
COOK MICROWIRE WIRE GUIDE |
COOK, INC. |
| K001087 |
04/04/2000 |
PTA BALLOON CATHETER |
COOK, INC. |
| K091385 |
05/10/2009 |
APPROACH HYDRO ST WIRE GUIDE, MODEL HMW |
COOK, INC. |
| K031766 |
06/09/2003 |
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER |
COOK, INC. |
| K051785 |
07/01/2005 |
FORMULA 418 BILIARY STENT |
COOK, INC. |
| K052036 |
07/28/2005 |
ATB ADVANCE PTA DILATATION CATHETER |
COOK, INC. |
| K022552 |
08/02/2002 |
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER |
COOK, INC. |
| K052539 |
09/15/2005 |
COOK FORMULA 418 BILIARY STENT SYSTEM |
COOK, INC. |
| K072625 |
09/17/2007 |
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) |
COOK, INC. |
| K032931 |
09/22/2003 |
PTA BALLOON CATHETER |
COOK, INC. |
| K072724 |
09/26/2007 |
CXI SUPPORT CATHETER |
COOK, INC. |
| K993455 |
10/13/1999 |
FLIPPER DETACHABLE EMBOLIZATION COIL |
COOK, INC. |
| K023504 |
10/18/2002 |
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER |
COOK, INC. |
| K063252 |
10/27/2006 |
ATB ADVANCED PTA DILATATION CATHETER |
COOK, INC. |
| K033875 |
12/15/2003 |
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER |
COOK, INC. |
| K073627 |
12/26/2007 |
FLEXOR EVAC ASPIRATION CATHETER |
COOK, INC. |
| K140593 |
03/07/2014 |
ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE |
COOK, INC. |
| K040505 |
02/27/2004 |
ZILVER 635 BILIARY STENT |
COOK, INC. |
| K042518 |
09/16/2004 |
ZILVER 518 BILIARY STENT |
COOK, INC. |
| K033348 |
10/20/2003 |
ZILVER 518 BILIARY STENT |
COOK, INC. |
| K043481 |
12/15/2004 |
MODIFICATION TO: ZILVER 635 BILIARY STENT |
COOK, INC. |
| K010016 |
01/02/2001 |
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER |
COOK, INC. |
| K010242 |
01/25/2001 |
COOK ZILVER BILIARY STENT |
COOK, INC. |
| K010450 |
02/15/2001 |
LIVER TAMPONADE BALLOON |
COOK, INC. |
| K010601 |
02/28/2001 |
FANELLI BILIARY STENT |
COOK, INC. |
| K013182 |
09/24/2001 |
TRIPLE LUMEN CENTRAL VENOUS CATHETER |
COOK, INC. |
| K013865 |
11/21/2001 |
TIP DEFLRCTING ENDOBRONCHIAL BLOCKER |
COOK, INC. |
| K010034 |
01/04/2001 |
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS- |
COOK, INC. |
| K000651 |
02/28/2000 |
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM |
COOK, INC. |
| K992121 |
06/23/1999 |
EMBOLIZATION COIL SYSTEM |
COOK, INC. |
| K992198 |
06/30/1999 |
URETHANE PICC LINE MODEL UPICS- |
COOK, INC. |
| K101877 |
07/06/2010 |
OCCLUSION BALLOON CATHETER MODEL OBC |
COOK, INC. |
| K063619 |
12/05/2006 |
FLIPPER DETACHABLE EMBOLIZATION COILS |
COOK, INC. |
| K052834 |
10/06/2005 |
MREYE EMBOLIZATION COIL |
COOK, INC. |
| K000855 |
03/16/2000 |
GUNTHER TULIP VENA CAVA MREYE FILTER SET |
COOK, INC. |
| K002286 |
07/27/2000 |
LDOB OCCLUSION BALLOON CATHETER |
COOK, INC. |
| K111244 |
05/03/2011 |
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) |
COOK, INC. |
| K101450 |
05/24/2010 |
CANTATA MICROCATHETER |
COOK, INC. |
| K112185 |
07/29/2011 |
FOURSNARE VASCULAR RETRIEVAL SNARE |
COOK, INC. |
| K072240 |
08/13/2007 |
GUNTHER TULIP VENA CAVA FILTER |
COOK, INC. |
| K122796 |
09/12/2012 |
CXI SUPPORT CATHETER |
COOK, INC. |
| K093052 |
09/30/2009 |
CROSSCATH SUPPORT CATHTER |
COOK, INC. |
| K080737 |
03/17/2008 |
MIRAFLEX HIGH FLOW MICROCATHETER |
COOK, INC. |
| K090822 |
03/26/2009 |
ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER |
COOK, INC. |
| K091527 |
05/26/2009 |
ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER |
COOK, INC. |
| K081690 |
06/17/2008 |
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER |
COOK, INC. |
| K073378 |
12/03/2007 |
ADVANCE 18LP PTA DILATATION CATHETER |
COOK, INC. |
| K122091 |
07/16/2012 |
COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY |
COOK, INC. |
| K132334 |
07/26/2013 |
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET |
COOK, INC. |
| K133597 |
11/22/2013 |
CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY |
COOK, INC. |
| K133634 |
11/26/2013 |
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET |
COOK, INC. |
| K101728 |
06/21/2010 |
FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE |
COOK, INC. |
| K093209 |
10/13/2009 |
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE |
COOK, INC. |
| K080037 |
01/07/2008 |
MODIFICATION TO ZILVER 635 BILIARY STENT |
COOK, INC. |
| K050698 |
03/17/2005 |
MODIFICATION TO:ZILVER 518 BILIARY STENT |
COOK, INC. |
| K051124 |
05/03/2005 |
ZILVER 635 BILIARY STENT |
COOK, INC. |
| K132020 |
07/01/2013 |
ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER |
COOK, INC. |
| K100283 |
02/01/2010 |
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC |
COOK, INC. |
| K130444 |
02/21/2013 |
H-30 HOLMIUM LASER SYSTEM |
COOK, INC. |
| K090624 |
03/09/2009 |
COOK MREYE EMBOLIZATION COILS |
COOK, INC. |
| K081113 |
04/18/2008 |
COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS |
COOK, INC. |
| K072148 |
08/03/2007 |
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER |
COOK, INC. |
| K093469 |
11/06/2009 |
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS |
COOK, INC. |
| K052841 |
10/07/2005 |
MIRA-FLEX 18 MICROCATHETER |
COOK, INC. |
| K071640 |
06/15/2007 |
VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM |
COOK, INC. |
| K032869 |
09/15/2003 |
COOK CODA BALLOON CATHETER |
COOK, INC. |
|
|
