AlboSure Vascular Patch

FDA UDI

Class II (US FDA UDI)

by LeMaitre Vascular, Inc.

Identity

Trade Name: AlboSure Vascular Patch FDA UDI
Generic Name: Cardiovascular patch, animal-derived FDA UDI
Device Name: AlboSure Vascular Patch 0.6x 7.5 cm FDA UDI
Model / Reference: AP06075T FDA UDI
Description: AlboSure Vascular Patch 0.6x 7.5 cm FDA UDI

Identifiers

Catalog Number: AP06075T FDA UDI
Primary DI / UDI-DI: 00840663104543 FDA UDI
510(k) Number: K101740 FDA UDI
FDA Product Code: DXZ FDA UDI
GMDN Term: Cardiovascular patch, animal-derived FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3470 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiovascular patch, animal-derived

AlboSure Vascular Patch by LeMaitre Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiovascular patch, animal-derived.

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VascuCel — ADMEDUS REGEN PTY LTD · Class II
Invengenx — Tisgenx · Class II
CanGaroo Envelope — Elutia Med LLC · Class II
Hemashield — Intervascular, Inc. · Class II
Peri-Guard — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II

Cleared under the same submission

K101740 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: LeMaitre Vascular, Inc.

Sources (1)

FDA UDI 50a48e3d-b61e-45cf-8766-028ebe041528 36 fields · synced Jun 9, 2026