FDA 510(k) Applications Submitted by CODMAN & SHURTLEFF, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K132281 |
07/23/2013 |
ReVive PV (Peripheral Vasculature) Thrombectomy Device |
Codman & Shurtleff, Inc. |
| K093973 |
12/24/2009 |
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM |
Codman & Shurtleff, Inc. |
| K053350 |
12/02/2005 |
MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS |
Codman & Shurtleff, Inc. |
| K120229 |
01/25/2012 |
ENVOY DISTAL ACCESS GUIDING CATHETER |
Codman & Shurtleff, Inc. |
| K112828 |
09/28/2011 |
REVIVE INTERMEDIATE CATHETER (REVIVE IC) |
Codman & Shurtleff, Inc. |
| K172022 |
07/05/2017 |
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) |
Codman & Shurtleff, Inc. |
| K172537 |
08/22/2017 |
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag |
Codman & Shurtleff, Inc. |
| K162437 |
08/31/2016 |
Codman EDS3 CSF External Drainage System |
Codman & Shurtleff, Inc. |
| K020667 |
03/01/2002 |
CODMAN HAKIM SHUNT SYSTEMS |
Codman & Shurtleff, Inc. |
| K031123 |
04/09/2003 |
CODMAN BACTISEAL BARIUM STRIPED CATHETERS |
Codman & Shurtleff, Inc. |
| K041518 |
06/07/2004 |
CODMAN DURAFORM DURAL GRAFT IMPLANT |
Codman & Shurtleff, Inc. |
| K023566 |
10/23/2002 |
CODMAN ISOCOOL BIPOLAR FORCEPS |
Codman & Shurtleff, Inc. |
| K071931 |
07/13/2007 |
CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 |
Codman & Shurtleff, Inc. |
| K073336 |
11/28/2007 |
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 |
Codman & Shurtleff, Inc. |
| K083895 |
12/29/2008 |
CODMAN ISOCOOL BIPOLAR FORCEPS |
Codman & Shurtleff, Inc. |
| K140080 |
01/14/2014 |
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB |
Codman & Shurtleff, Inc. |
| K140307 |
02/07/2014 |
ENVOY GUIDING CATHETER |
Codman & Shurtleff, Inc. |
| K150319 |
02/09/2015 |
MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS |
CODMAN & SHURTLEFF, INC. |
| K133625 |
11/26/2013 |
AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & |
Codman & Shurtleff, Inc. |
| K992591 |
08/02/1999 |
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS |
Codman & Shurtleff, Inc. |
| K992905 |
08/30/1999 |
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM |
Codman & Shurtleff, Inc. |
| K002798 |
09/07/2000 |
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS |
Codman & Shurtleff, Inc. |
| K003322 |
10/24/2000 |
CODMAN BACTISEAL CATHETERS |
Codman & Shurtleff, Inc. |
| K003549 |
11/17/2000 |
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS |
Codman & Shurtleff, Inc. |
| K152481 |
08/31/2015 |
DURAFORM Dural Graft Implant |
CODMAN & SHURTLEFF, INC. |
| K100351 |
02/12/2010 |
NEUROSCOUT STEERABLE GUIDEWIRE |
Codman & Shurtleff, Inc. |
| K121776 |
06/18/2012 |
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE |
Codman & Shurtleff, Inc. |
| K052449 |
09/06/2005 |
CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189 |
Codman & Shurtleff, Inc. |
| K061568 |
06/06/2006 |
CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 |
Codman & Shurtleff, Inc. |
| K102961 |
10/05/2010 |
HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM |
Codman & Shurtleff, Inc. |
| K050739 |
03/21/2005 |
CODMAN VPV SYSTEM, MODEL 82-3192 |
Codman & Shurtleff, Inc. |
| K093184 |
10/09/2009 |
ENVOY GUIDING CATHETERS |
Codman & Shurtleff, Inc. |
| K041296 |
05/14/2004 |
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI |
Codman & Shurtleff, Inc. |
| K013877 |
11/23/2001 |
CODMAN SLIM-LOC SYSTEM |
Codman & Shurtleff, Inc. |
| K122118 |
07/17/2012 |
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM |
Codman & Shurtleff, Inc. |
| K021653 |
05/20/2002 |
CODMAN BACTISEAL EVD CATHETER SET |
Codman & Shurtleff, Inc. |
| K120686 |
03/06/2012 |
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM |
Codman & Shurtleff, Inc. |
| K191237 |
05/08/2019 |
CERENOVUS Large Bore Catheter |
Codman & Shurtleff, Inc. |
| K193380 |
12/05/2019 |
CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set |
Codman & Shurtleff, Inc. |
| K003564 |
11/20/2000 |
HAKIM PROGRAMMER AND TRANSMITTER |
Codman & Shurtleff, Inc. |
| K033395 |
10/23/2003 |
CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1 |
Codman & Shurtleff, Inc. |
| K120117 |
01/17/2012 |
CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM |
Codman & Shurtleff, Inc. |
| K153347 |
11/20/2015 |
Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit |
CODMAN & SHURTLEFF, INC. |
| K091921 |
06/30/2009 |
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP |
Codman & Shurtleff, Inc. |
| K092437 |
08/07/2009 |
CODMAN STERILIZATION CONTAINERS |
Codman & Shurtleff, Inc. |
| K071791 |
07/02/2007 |
MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 |
Codman & Shurtleff, Inc. |
| K071776 |
06/29/2007 |
ANEUROPLASTIC, MODEL 43-1290 |
Codman & Shurtleff, Inc. |
| K123560 |
11/19/2012 |
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM |
Codman & Shurtleff, Inc. |
| K090348 |
02/11/2009 |
CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET |
Codman & Shurtleff, Inc. |
| K110751 |
03/18/2011 |
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER |
Codman & Shurtleff, Inc. |
| K091346 |
05/07/2009 |
CODMAN HAKIM MICRO II VALVE |
Codman & Shurtleff, Inc. |
| K102589 |
09/09/2010 |
CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER |
Codman & Shurtleff, Inc. |
| K953568 |
07/31/1995 |
CODMAN FIDUCIAL MARKER SYSTEM |
Codman & Shurtleff, Inc. |
| K061876 |
07/03/2006 |
CODMAN VPV SYSTEM, MODEL 82-3192 |
Codman & Shurtleff, Inc. |
| K053107 |
11/04/2005 |
CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD |
Codman & Shurtleff, Inc. |
| K171747 |
06/13/2017 |
MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and |
Codman & Shurtleff, Inc. |
| K171653 |
06/05/2017 |
YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up |
Codman & Shurtleff, Inc. |
| K162563 |
09/14/2016 |
YOGA Microcatheter |
CODMAN & SHURTLEFF, INC. |
|
|
