Hemashield

FDA UDI

Class II (US FDA UDI)

by Intervascular, Inc.

Identity

Trade Name: Hemashield FDA UDI
Generic Name: Synthetic vascular graft FDA UDI
Device Name: Hemashield Platinum Woven ThoracoAbdominal 4 Branch Double Velour Vascular Graft with Graft Sizer Accessory FDA UDI
Model / Reference: M00202175426T0 FDA UDI
Description: Hemashield Platinum Woven ThoracoAbdominal 4 Branch Double Velour Vascular Graft with Graft Sizer Accessory FDA UDI

Identifiers

Catalog Number: M00202175426T0 FDA UDI
Primary DI / UDI-DI: 00384401018766 FDA UDI
510(k) Number: K052302 FDA UDI
FDA Product Code: MAL FDA UDI
GMDN Term: Synthetic vascular graft FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3450 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

Yes

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

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 8 Millimeter FDA UDI
Lumen/Inner Diameter — 10 Millimeter FDA UDI
Lumen/Inner Diameter — 26 Millimeter FDA UDI
Length — 47 Centimeter FDA UDI

Category: Synthetic vascular graft

Hemashield by Intervascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Gelweave™ — VASCUTEK LTD · Class II
Zenith — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class III
ADVANTA SLIDER GDS — Atrium Medical Corp. · Class II
Gelweave Vascular Prostheses — VASCUTEK LTD · Class II

Cleared under the same submission

K052302 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: Intervascular, Inc.

Sources (1)

FDA UDI 8776fa0a-d65a-489a-a6c0-90e0b36209c7 38 fields · synced May 30, 2026