Medical Device Manufacturer · US , Mchenry , IL

Codman & Shurtleff, Inc.

152 submissions · 151 cleared · Since 1976
152
Total
151
Cleared
0
Denied

Codman & Shurtleff, Inc. — FDA 510(k) Submissions

Codman & Shurtleff, Inc. has submitted 152 FDA 510(k) premarket notifications since 1976, of which 151 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Shunt, Central Nervous System And Components, Device, Monitoring, Intracranial Pressure, Catheter, Percutaneous, Device, Neurovascular Embolization, Drills, Burrs, Trephines & Accessories (compound, Powered) . Use the specialty filter in the sidebar to narrow results.

152 devices
1–25 of 152
CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
K193380 · NRY Catheter, Thrombus Retriever · Neurology
Jul 2020 228d
CERENOVUS Large Bore Catheter
K191237 · DQY Catheter, Percutaneous · Neurology
Nov 2019 184d
CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
K173192 · GWM Device, Monitoring,... · Neurology
Nov 2017 37d
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
K172537 · JXG Shunt, Central Nervous... · Neurology
Oct 2017 55d
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
K172022 · JXG Shunt, Central Nervous... · Neurology
Oct 2017 90d
GALAXY G3 Mini Microcoil Delivery System
K171862 · HCG Device, Neurovascular... · Neurology
Sep 2017 95d
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 GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System
K171747 · HCG Device, Neurovascular... · Neurology
Jul 2017 31d
YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
K171653 · DQY Catheter, Percutaneous · Cardiovascular
Jul 2017 28d
YOGA Microcatheter
K162563 · DQY Catheter, Percutaneous · Cardiovascular
Jan 2017 113d
Codman EDS3 CSF External Drainage System
K162437 · JXG Shunt, Central Nervous... · Neurology
Oct 2016 58d
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
K153347 · GWM Device, Monitoring,... · Neurology
Aug 2016 273d
DURAFORM Dural Graft Implant
K152481 · GXQ Dura Substitute · Neurology
Oct 2015 60d
MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
K150319 · HCG Device, Neurovascular... · Neurology
Jun 2015 123d
CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable
K142429 · HCG Device, Neurovascular... · Neurology
Dec 2014 117d
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
K140080 · DQY Catheter, Percutaneous · Cardiovascular
Apr 2014 100d
ENVOY GUIDING CATHETER
K140307 · DQY Catheter, Percutaneous · Cardiovascular
Apr 2014 73d
AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &
K133625 · MOF Guide, Wire, Catheter,... · Neurology
Feb 2014 90d
ReVive PV (Peripheral Vasculature) Thrombectomy Device
K132281 · QEW Peripheral Mechanical... · Cardiovascular
Aug 2013 38d
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM
K123560 · HCG Device, Neurovascular... · Neurology
Jan 2013 67d
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
K121776 · DQX Wire, Guide, Catheter · Cardiovascular
Aug 2012 57d
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
K122118 · JXG Shunt, Central Nervous... · Neurology
Aug 2012 17d
CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM
K120117 · KCT Sterilization Wrap... · General Hospital
Apr 2012 90d
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
K120686 · HCG Device, Neurovascular... · Neurology
Apr 2012 29d
ENVOY DISTAL ACCESS GUIDING CATHETER
K120229 · DQY Catheter, Percutaneous · Cardiovascular
Feb 2012 30d
REVIVE INTERMEDIATE CATHETER (REVIVE IC)
K112828 · DQY Catheter, Percutaneous · Cardiovascular
Oct 2011 27d

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