Identifiers
- 510(k) Number
- K221294 FDA 510(k)
- FDA Product Code
- MJN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4450 FDA 510(k)
- Regulation Number
- 870.4450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESU FDA 510(k)
The preCARDIA Occlusion System is a Catheter, Intravascular Occluding, Temporary, designed for selective occlusion of the inferior or superior vena cava. It functions as a vascular clamp to temporarily control or stop blood flow during perioperative procedures, including emergency hemorrhage management and blood pressure monitoring.
This system is supplied as a reusable device comprising a balloon occlusion catheter, controller, and console. It is regulated under 21 CFR 870.4450 as a Class II medical device (Product Code: MJN) and has received FDA 510(k) clearance (K221294). The device is intended for use in cardiovascular applications and is intended for temporary occlusion only.
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: preCARDIA Occlusion System (K221294) — FDA 510(k) | Innolitics, K221294 - preCARDIA Occlusion System - Cardiovascular, PDF Abiomed Inc. - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221294 | Class II | Active |
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Manufacturer
- Manufacturer
- Abiomed, Inc.
Sources (1)
- FDA 510(k) K221294 24 fields · synced Sep 19, 2026