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FDA 510(k)

TISSUE PATCH, TISSUE GRAFT

K-Number: K921895 · 1992-11-04

ApplicantBio-Vascular, Inc.
Decision Date1992-11-04
Product CodeDXZ
Advisory CommitteeCV
DecisionUnknown

Device Summary

TISSUE PATCH, TISSUE GRAFT 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 1992-11-04 under 510(k) number K921895. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the TISSUE PATCH, TISSUE GRAFT?

TISSUE PATCH, TISSUE GRAFT is a medical device that received FDA 510(k) clearance on 1992-11-04. The listed applicant is Bio-Vascular, Inc.. The 510(k) number is K921895.

When did TISSUE PATCH, TISSUE GRAFT receive FDA 510(k) clearance?

TISSUE PATCH, TISSUE GRAFT received FDA 510(k) clearance on 1992-11-04, under 510(k) number K921895.

Who is the listed applicant for TISSUE PATCH, TISSUE GRAFT?

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 TISSUE PATCH, TISSUE GRAFT?

The FDA product code for TISSUE PATCH, TISSUE GRAFT is DXZ.

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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: 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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