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: M00202175420T0 FDA UDI
Description: Hemashield Platinum Woven ThoracoAbdominal 4 Branch Double Velour Vascular Graft with Graft Sizer Accessory FDA UDI

Identifiers

Catalog Number: M00202175420T0 FDA UDI
Primary DI / UDI-DI: 00384401514381 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 — 20 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

Similar devices

Also classified as Synthetic vascular graft.

Gelweave™ — VASCUTEK LTD · Class II
GORE PROPATEN Vascular Graft Pediatric Shunt — W. L. GORE & ASSOCIATES, INC · Class II
Gelweave™ — VASCUTEK LTD · Class II
COOK — William Cook Europe ApS · Class III
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Intervascular, Inc.

Sources (1)

FDA UDI e74ffde5-1c65-42dd-94d9-fd65f6148202 38 fields · synced Jun 6, 2026