Search FDA 510(k) Database

Cleared Jul 20, 2020

CERENOVUS Large Bore Catheter

K193380 · NRY

Codman & Shurtleff, Inc.

Neurology · 228d

Cleared Nov 08, 2019

CERENOVUS Large Bore Catheter

K191237 · DQY

Codman & Shurtleff, Inc.

Neurology · 184d

Cleared Nov 08, 2017

CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit,...

K173192 · GWM

Codman & Shurtleff, Inc.

Neurology · 37d

Cleared Oct 16, 2017

Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage...

K172537 · JXG

Codman & Shurtleff, Inc.

Neurology · 55d

Cleared Oct 03, 2017

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)

K172022 · JXG

Codman & Shurtleff, Inc.

Neurology · 90d

Cleared Sep 25, 2017

GALAXY G3 Mini Microcoil Delivery System

K171862 · HCG

Codman & Shurtleff, Inc.

Neurology · 95d

Cleared Jul 14, 2017

MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18...

K171747 · HCG

Codman & Shurtleff, Inc.

Neurology · 31d

Cleared Jul 03, 2017

YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up

K171653 · DQY

Codman & Shurtleff, Inc.

Cardiovascular · 28d

Cleared Jan 05, 2017

YOGA Microcatheter

K162563 · DQY

Codman & Shurtleff, Inc.

Cardiovascular · 113d

Cleared Oct 28, 2016

Codman EDS3 CSF External Drainage System

K162437 · JXG

Codman & Shurtleff, Inc.

Neurology · 58d

Cleared Aug 19, 2016

Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit,...

K153347 · GWM

Codman & Shurtleff, Inc.

Neurology · 273d

Cleared Oct 30, 2015

DURAFORM Dural Graft Implant

K152481 · GXQ

Codman & Shurtleff, Inc.

Neurology · 60d

Cleared Jun 12, 2015

MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH...

K150319 · HCG

Codman & Shurtleff, Inc.

Neurology · 123d

Cleared Dec 24, 2014

CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT...

K142429 · HCG

Codman & Shurtleff, Inc.

Neurology · 117d

Cleared Apr 24, 2014

ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB,...

K140080 · DQY

Codman & Shurtleff, Inc.

Cardiovascular · 100d

Cleared Apr 21, 2014

ENVOY GUIDING CATHETER

K140307 · DQY

Codman & Shurtleff, Inc.

Cardiovascular · 73d

Cleared Feb 24, 2014

AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT...

K133625 · MOF

Codman & Shurtleff, Inc.

Neurology · 90d

Cleared Aug 30, 2013

ReVive PV (Peripheral Vasculature) Thrombectomy Device

K132281 · QEW

Codman & Shurtleff, Inc.

Cardiovascular · 38d

Cleared Jan 25, 2013

VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT...

K123560 · HCG

Codman & Shurtleff, Inc.

Neurology · 67d

Cleared Aug 14, 2012

AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE

K121776 · DQX

Codman & Shurtleff, Inc.

Cardiovascular · 57d

Cleared Aug 03, 2012

HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM

K122118 · JXG

Codman & Shurtleff, Inc.

Neurology · 17d

Cleared Apr 16, 2012

CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM

K120117 · KCT

Codman & Shurtleff, Inc.

General Hospital · 90d

Cleared Apr 04, 2012

ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM

K120686 · HCG

Codman & Shurtleff, Inc.

Neurology · 29d

Cleared Feb 24, 2012

ENVOY DISTAL ACCESS GUIDING CATHETER

K120229 · DQY

Codman & Shurtleff, Inc.

Cardiovascular · 30d