Chase Coronary Ostial Perfusion Cannula
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K971041 FDA 510(k)
- FDA Product Code
- DWF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4210 FDA 510(k)
- Regulation Number
- 870.4210 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Chase Coronary Ostial Perfusion Cannula is a vascular cannula used in conjunction with cardiopulmonary bypass surgery. It is designed for the delivery of cardioplegia solutions directly to the coronary ostia.
This device is authorized under FDA 510(k) clearance K971041. It is classified under regulation number 870.4210 for use in cardiovascular procedures.
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: CHASE CORONARY OSTIAL PERFUSION CANNULA (K971041) — FDA 510 (k ..., PDF Summary of Safety and Effectiveness Chase Coronary Ostial Perfusion Cannula, PDF K971041 - Chase Coronary Ostial Perfusion Cannula, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K971041 | Class II | Active |
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Manufacturer
- Manufacturer
- Chase Medical, Inc.
Sources (1)
- FDA 510(k) K971041 24 fields · synced Sep 21, 2026