Identifiers
- 510(k) Number
- K060396 FDA 510(k)
- FDA Product Code
- DXZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3470 FDA 510(k)
- Regulation Number
- 870.3470 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ivena Vascular Patch is a patch, pledget and intracardiac device made of PETP, PTFE, and polypropylene. It is classified as a cardiovascular device under regulation number 870.3470.
The device received FDA 510(k) clearance (K060396) on May 12, 2006, as substantially equivalent to a predicate device. It is manufactured by Atrium Medical Corp. in Hudson, NH, and is intended for use in cardiovascular applications.
Frequently asked questions
What is the IVENA Vascular Patch used for?
The IVENA Vascular Patch is intended for use in cardiovascular applications as a patch, pledget, and intracardiac device, designed for implantation in vascular and cardiac procedures where synthetic patch material is required.
What materials is the IVENA Vascular Patch made from?
The IVENA Vascular Patch is constructed from a combination of PETP (polyethylene terephthalate polyester), PTFE (polytetrafluoroethylene), and polypropylene, providing a biocompatible synthetic material suitable for cardiovascular implantation.
How was the IVENA Vascular Patch cleared for market?
The IVENA Vascular Patch received FDA 510(k) clearance under submission K060396 on May 12, 2006, determined to be substantially equivalent to a predicate device, allowing its legal marketing in the United States for cardiovascular use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060396 | Class II | Active |
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Manufacturer
- Manufacturer
- Atrium Medical Corp.
Sources (1)
- FDA 510(k) K060396 24 fields · synced Sep 23, 2026