Identity
- Trade Name
- HEMASHIELD GOLD Knitted MICROVEL Double Velour Vascular Grafts EUDAMEDHemashield FDA UDI
- Generic Name
- Synthetic vascular graft FDA UDI
- Device Name
- HEMASHIELD GOLD Knitted MICROVEL Double Velour Vascular Grafts EUDAMEDHemashield Gold Knitted Microvel Straight Double Velour Vascular Graft with Graft Sizer Accessory FDA UDI
- Model / Reference
- M002020952140 EUDAMEDFDA UDI
- Description
- Hemashield Gold Knitted Microvel Straight Double Velour Vascular Graft with Graft Sizer Accessory FDA UDI
Identifiers
- Catalog Number
- M002020952140 FDA UDI
- Primary DI / UDI-DI
- 00384401017509 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00384401017509 EUDAMED
- 510(k) Number
- K954848 FDA UDI
- FDA Product Code
- MAL FDA UDI
- EMDN Code
- P070102010101 DACRON VASCULAR PROSTHESES, STRAIGHT, KNITTED EUDAMED
- GMDN Term
- Synthetic vascular graft FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.3450 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 14 Millimeter FDA UDILength — 30 Centimeter FDA UDI
Category: Synthetic vascular graft
Hemashield by Intervascular, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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
K954848 also covers:
- Hemashield — Intervascular, Inc.
- Hemashield — Intervascular, Inc.
- Hemashield — Intervascular, Inc.
- Hemashield — Intervascular, Inc.
- Hemashield — Intervascular, Inc.
- Hemashield — Intervascular, Inc.
- Hemashield — Intervascular, Inc.
- Hemashield — Intervascular, Inc.
- Hemashield — Intervascular, Inc.
- Hemashield — Intervascular, Inc.
- Hemashield — Intervascular, Inc.
- Hemashield — Intervascular, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Intervascular, Inc.
Sources (2)
- FDA UDI b19e3a2e-729f-4ef5-939f-623c7835129b 38 fields · synced Aug 1, 2026
- EUDAMED 39a3a0b4-b3aa-483d-9234-c33108950b45 61 fields · synced Aug 1, 2026