CardiaMend

FDA UDI

Class II (US FDA UDI)

by Helios Cardio Inc.

Identity

Trade Name: CardiaMend FDA UDI
Generic Name: Cardiovascular patch, animal-derived FDA UDI
Device Name: CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 16 cm FDA UDI
Model / Reference: CMUS-10NS-0816 FDA UDI
Description: CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 16 cm FDA UDI

Identifiers

Catalog Number: CMUS-10NS-0816 FDA UDI
Primary DI / UDI-DI: 00850023375018 FDA UDI
510(k) Number: K210331 FDA UDI
FDA Product Code: PSQ 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: Length — 8 Centimeter FDA UDI
Width — 16 Centimeter FDA UDI
Height — 1 Millimeter FDA UDI

Category: Cardiovascular patch, animal-derived

CardiaMend by Helios Cardio Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiovascular patch, animal-derived.

Biotronik BioEnvelope — Elutia Med LLC · Class II
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

Cleared under the same submission

K210331 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: Helios Cardio Inc.

Sources (1)

FDA UDI 42192015-4d45-4c4a-9e51-206c3478ffb0 38 fields · synced May 30, 2026