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FDA 510(k)

ALBOSURE POLYESTER VASCULAR PATCH

K-Number: K101740 · 2010-09-20

ApplicantLeMaitre Vascular, Inc.
Decision Date2010-09-20
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ALBOSURE POLYESTER VASCULAR PATCH is the device name listed in this FDA 510(k) record. The listed applicant is LeMaitre Vascular, Inc.. It received FDA 510(k) clearance on 2010-09-20 under 510(k) number K101740. 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 ALBOSURE POLYESTER VASCULAR PATCH?

ALBOSURE POLYESTER VASCULAR PATCH is a medical device that received FDA 510(k) clearance on 2010-09-20. The listed applicant is LeMaitre Vascular, Inc.. The 510(k) number is K101740.

When did ALBOSURE POLYESTER VASCULAR PATCH receive FDA 510(k) clearance?

ALBOSURE POLYESTER VASCULAR PATCH received FDA 510(k) clearance on 2010-09-20, under 510(k) number K101740.

Who is the listed applicant for ALBOSURE POLYESTER VASCULAR PATCH?

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

What is the FDA product code for ALBOSURE POLYESTER VASCULAR PATCH?

The FDA product code for ALBOSURE POLYESTER VASCULAR PATCH is DXZ.

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Other records listing LeMaitre 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.

K212894PhasTIPPK183513XenoSure Dura Biologic PatchK173323AnastoClip GC Closure SystemK152833Pruitt F3-S Polyurethane Carotid ShuntK133026UNBALLOON NON-OCCLUSION MODELING CATHETERK132022LEMAITRE 8F OCCLUSION CATHETER

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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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