Ochsner 50 Vascular Prosthesis
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K905270 FDA 510(k)
- FDA Product Code
- DSY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3450 FDA 510(k)
- Regulation Number
- 870.3450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ochsner 50 Vascular Prosthesis is a vascular graft prosthesis, classified as a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter. It is a medical device used in the cardiovascular medical specialty. The device is substantially equivalent to other devices on the market.
The Ochsner 50 Vascular Prosthesis is supplied with a product code of DSY and is classified as a class 2 device. It has been cleared by the FDA with a traditional clearance type and has a regulation number of 870.3450. The device has been assigned a K number of K905270 and has been reviewed by the Cardiovascular advisory committee.
Frequently asked questions
What is the Ochsner 50 Vascular Prosthesis used for?
The Ochsner 50 Vascular Prosthesis is used in the cardiovascular medical specialty as a vascular graft prosthesis, classified as a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter.
How is the Ochsner 50 Vascular Prosthesis supplied?
The device is supplied with a product code of DSY and is classified as a class 2 device.
Is the Ochsner 50 Vascular Prosthesis sterile?
The provided data does not specify the sterility of the Ochsner 50 Vascular Prosthesis, it is recommended to consult the manufacturer or the device's labeling for this information.
What is the regulatory classification of the Ochsner 50 Vascular Prosthesis?
The Ochsner 50 Vascular Prosthesis has been cleared by the FDA with a traditional clearance type and has a regulation number of 870.3450, it is also classified as a class 2 device.
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. Sources consulted: OCHSNER 50 VASCULAR PROSTHESIS (K905270) — FDA 510 (k) | Innolitics, OCHSNER 50 VASCULAR PROSTHESIS 510 (k) K905270 - FDA.report, FDA Browser - Cleared 510 (K) - INTERVASCULAROCHSNER 50 AND OCHSNER 500 ..., INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR 510 (k) K854845 - FDA ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K905270 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Intervascular, Inc.
Sources (1)
- FDA 510(k) K905270 24 fields · synced Sep 27, 2026