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FDA 510(k)

DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE

K-Number: K950956 · 1995-06-02

ApplicantBio-Vascular, Inc.
Decision Date1995-06-02
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Vascular, Inc.. It received FDA 510(k) clearance on 1995-06-02 under 510(k) number K950956. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE?

DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE is a medical device that received FDA 510(k) clearance on 1995-06-02. The listed applicant is Bio-Vascular, Inc.. The 510(k) number is K950956.

When did DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE receive FDA 510(k) clearance?

DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE received FDA 510(k) clearance on 1995-06-02, under 510(k) number K950956.

Who is the listed applicant for DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE?

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

What is the FDA product code for DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE?

The FDA product code for DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE is GXQ.

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Other records listing Bio-Vascular, 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.

K002233BVI SLINGK992537PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATEDK983602CV PERI-GUARD AND VASCU-GUARDK983581OCU-GUARD AND OCU-GUARD SUPPLEK983162PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASCK981624FLO-THRU

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Related Devices (Code: GXQ)

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.

K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc.K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.K223445ArtiFasciaNurami Medical , Ltd.K212943SyntheCel Dura RepairSynthes (USA) Products, LLCK183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc.K172603Cerafix Dura SubstituteAcera Surgical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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