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FDA 510(k)

NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT

K-Number: K022638 · 2002-10-31

ApplicantNeurorecovery, Inc.
Decision Date2002-10-31
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Neurorecovery, Inc.. It received FDA 510(k) clearance on 2002-10-31 under 510(k) number K022638. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT?

NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT is a medical device that received FDA 510(k) clearance on 2002-10-31. The listed applicant is Neurorecovery, Inc.. The 510(k) number is K022638.

When did NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT receive FDA 510(k) clearance?

NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT received FDA 510(k) clearance on 2002-10-31, under 510(k) number K022638.

Who is the listed applicant for NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT?

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

What is the FDA product code for NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT?

The FDA product code for NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT is GWM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Neurorecovery, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K051599NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT

Related Devices (Code: GWM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Official Source

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