Angiographic Catheter, Model Angios
FDA 510(k)Class II (US FDA 510(k))
by Oscor Inc.
Identifiers
- 510(k) Number
- K092118 FDA 510(k)
- FDA Product Code
- DQO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1200 FDA 510(k)
- Regulation Number
- 870.1200 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Angiographic Catheter, Model Angios, is a catheter used for diagnostic purposes in cardiology. It is designed to navigate through blood vessels to provide diagnostic information. The device is classified as a Catheter, Intravascular, Diagnostic. It is available in various curve, size, and length configurations.
The Angiographic Catheter, Model Angios, is supplied in different sizes and configurations. It has been cleared by the FDA under the 510(k) clearance, with the reference number K092118. The device is intended for use in diagnostic cardiology and is classified as a Class II device with special controls. It is manufactured by Oscor Inc. and has been cleared for use since January 13, 2010.
Frequently asked questions
What is the Angiographic Catheter, Model Angios, used for?
The Angiographic Catheter, Model Angios, is used for diagnostic purposes in cardiology, providing diagnostic information by navigating through blood vessels.
Is the Angiographic Catheter, Model Angios, available in different sizes and configurations?
Yes, the Angiographic Catheter, Model Angios, is supplied in various curve, size, and length configurations to accommodate different patient needs.
What is the regulatory status of the Angiographic Catheter, Model Angios?
The Angiographic Catheter, Model Angios, has been cleared by the FDA under the 510(k) clearance, with the reference number K092118, indicating it is substantially equivalent to a predicate 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: Angiography catheter - Angios Classic® - Oscor - blood vessel, Angios Classic angiography catheter for diagnostic cardiology - OSCOR, K092118 FDA 510(k) - ANGIOGRAPHIC CATHETER | Oscor, Inc., Angios Classic angiography catheter for diagnostic cardiology - OSCOR
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092118 | Class II | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K092118 24 fields · synced Sep 26, 2026