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FDA 510(k)

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

N.º K: K173192 · 2017-11-08

SolicitanteCodman & Shurtleff, Inc.
Fecha de decisión2017-11-08
Código de productoGWM
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

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 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 2017-11-08 under 510(k) number K173192. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 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?

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 is a medical device that received FDA 510(k) clearance on 2017-11-08. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K173192.

When did 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 receive FDA 510(k) clearance?

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 received FDA 510(k) clearance on 2017-11-08, under 510(k) number K173192.

Who is the listed applicant for 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?

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 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?

The FDA product code for 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 is GWM.

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Dispositivos relacionados (Código: GWM)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysaK250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLRaumedic AGK240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production CorporationK201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation

Fuente oficial

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