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FDA 510(k)

CARDIOVASCULAR REPAIR PATCH

K-Number: K905073 · 1991-12-20

ApplicantImpra, Inc.
Decision Date1991-12-20
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOVASCULAR REPAIR PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Impra, Inc.. It received FDA 510(k) clearance on 1991-12-20 under 510(k) number K905073. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVASCULAR REPAIR PATCH?

CARDIOVASCULAR REPAIR PATCH is a medical device that received FDA 510(k) clearance on 1991-12-20. The listed applicant is Impra, Inc.. The 510(k) number is K905073.

When did CARDIOVASCULAR REPAIR PATCH receive FDA 510(k) clearance?

CARDIOVASCULAR REPAIR PATCH received FDA 510(k) clearance on 1991-12-20, under 510(k) number K905073.

Who is the listed applicant for CARDIOVASCULAR REPAIR PATCH?

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

What is the FDA product code for CARDIOVASCULAR REPAIR PATCH?

The FDA product code for CARDIOVASCULAR REPAIR PATCH is DXZ.

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Other records listing Impra, 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.

K004012IMPRA CARBOFLO EPTFE VASCULAR GRAFTSK004011IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESSK991027BI-DIRECTIONAL TUNNELERK983769DISTAFLO BYPASS GRAFTK983861DISTAFLO BYPASS GRAFTK983064IMPRA HIGH POROSITY GRAFT

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Related Devices (Code: DXZ)

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.

K240775PeriBeam® Pericardial MembraneTamabioK200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd.K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc.K162579VascuCelAdmedus Regen Pty, Ltd.K152127CorMatrix TykeCormatrix Cardiovascular, Inc.K122306SYNOVIS COLLAGEN MATRIX (TBD)Synovis Surgical Innovations

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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