FDA 510(k)

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)

Numéro K : K172022 · 2017-10-03

Date de décision2017-10-03

Code produitJXG

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2017-10-03 under 510(k) number K172022. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)?

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) is a medical device that received FDA 510(k) clearance on 2017-10-03. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K172022.

When did CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) receive FDA 510(k) clearance?

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) received FDA 510(k) clearance on 2017-10-03, under 510(k) number K172022.

Who is the listed applicant for CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)?

The FDA 510(k) record lists Codman & Shurtleff, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)?

The FDA product code for CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) is JXG.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Autres dossiers indiquant Codman & Shurtleff, Inc. en tant que demandeur

K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set K191237CERENOVUS Large Bore Catheter K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag K171862GALAXY G3 Mini Microcoil Delivery System K171747MICRUSFRAME 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

Voir tous les 11 dispositifs →

Dispositifs connexes (Code : JXG)

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production Corporation K251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)Sophysa K252514EVAC-MRIPhasor Health, LLC K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation K243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)Integra Lifesciences Production Corporation

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.