Identity
- Trade Name
- ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II FDA PMA
- Generic Name
- GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE FDA PMA
Identifiers
- PMA Number
- P920027 FDA PMA
- FDA Product Code
- MAL FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 870.3450 FDA PMA
- Regulation Number
- 870.3450 FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APRL FDA PMA
The Albumin Coated Debakey Vascular-II is a synthetic/biologic composite vascular graft, classified as a synthetic or biologic vascular graft under the FDA’s nomenclature. It is designed to provide vascular reconstruction by replacing or bypassing damaged or diseased blood vessels, supporting blood flow in cardiovascular procedures.
This device is supplied sterile and intended for single-use, with approval under an FDA Premarket Approval (PMA) application (PMA P920027). It is categorized under device class II (MAL product code) and regulated under FDA regulation 870.3450, ensuring compliance with cardiovascular surgical standards. The graft is available in various sizes as indicated by the registration numbers and is intended for use in controlled clinical settings.
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_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P920027 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA PMA P920027 24 fields · synced Sep 18, 2026