VasCure for Vascular Repair

FDA UDI

Class II (US FDA UDI)

by Elutia Med LLC

Identity

Trade Name: VasCure for Vascular Repair FDA UDI
Generic Name: Cardiovascular patch, animal-derived FDA UDI
Device Name: VasCure for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. VasCure for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels. FDA UDI
Model / Reference: CMCV-013-609 FDA UDI
Description: VasCure for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. VasCure for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels. FDA UDI

Identifiers

Primary DI / UDI-DI: 00859389005140 FDA UDI
510(k) Number: K140789 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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Height — 1 Centimeter FDA UDI
Width — 10 Centimeter FDA UDI

Category: Cardiovascular patch, animal-derived

VasCure for Vascular Repair by Elutia Med LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiovascular patch, animal-derived.

XenoSure Biologic Patch — LeMaitre Vascular, Inc. · Class II
CardioCel Bioscaffold Patch 5 cm X 8 cm — LeMaitre Vascular, Inc. · Class II
VASCU-GUARD Peripheral Vascular Patch — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
Invengenx — Tisgenx · Class II
VascuCel — ADMEDUS REGEN PTY LTD · Class II
AlboSure Vascular Patch — LeMaitre Vascular, Inc. · Class II
XenoSure Biologic Patch — LeMaitre Vascular, Inc. · Class II
AlboSure Vascular Patch — LeMaitre Vascular, Inc. · Class II

Cleared under the same submission

K140789 also covers:

VasCure for Vascular Repair — Elutia Med LLC

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: Elutia Med LLC

Sources (1)

FDA UDI 7b6327b0-c122-4b1a-b8f6-4f81c55c9cdc 37 fields · synced Jun 1, 2026