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FDA 510(k)

ULTRA LOW POROSITY DACRON WOVEN PATCH

K-Number: K921659 · 1992-11-25

ApplicantIntervascular, Inc.
Decision Date1992-11-25
Product CodeDXZ
Advisory CommitteeCV
DecisionUnknown

Device Summary

ULTRA LOW POROSITY DACRON WOVEN PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Intervascular, Inc.. It received FDA 510(k) clearance on 1992-11-25 under 510(k) number K921659. 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 ULTRA LOW POROSITY DACRON WOVEN PATCH?

ULTRA LOW POROSITY DACRON WOVEN PATCH is a medical device that received FDA 510(k) clearance on 1992-11-25. The listed applicant is Intervascular, Inc.. The 510(k) number is K921659.

When did ULTRA LOW POROSITY DACRON WOVEN PATCH receive FDA 510(k) clearance?

ULTRA LOW POROSITY DACRON WOVEN PATCH received FDA 510(k) clearance on 1992-11-25, under 510(k) number K921659.

Who is the listed applicant for ULTRA LOW POROSITY DACRON WOVEN PATCH?

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

What is the FDA product code for ULTRA LOW POROSITY DACRON WOVEN PATCH?

The FDA product code for ULTRA LOW POROSITY DACRON WOVEN PATCH is DXZ.

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Other records listing Intervascular, 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.

K990800INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESISK984294MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESESK983819INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THINK970843INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESESK964625HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESESK913143OCHSNER ULP BIFURCATION VASCULAR PROTHESIS

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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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