Datascope Percor Stat-Dl 9.5 Fr. 25, 34 And 40cc Intra-Aoric Balloons With Alte…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K980780 FDA 510(k)
- FDA Product Code
- DSP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3535 FDA 510(k)
- Regulation Number
- 870.3535 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Datascope Percor STAT-DL 9.5 Fr. Intra-Aortic Balloons are designed as a component of an intra-aortic balloon pump system. These devices are intended for temporary circulatory support by augmenting cardiac output through counterpulsation, improving coronary and systemic perfusion during acute myocardial infarction, cardiogenic shock, or post-cardiac surgery recovery.
These balloons are supplied in three volumes (25cc, 34cc, and 40cc) and are used in conjunction with a compatible control unit and sheath (optional). The device is classified as Class II under FDA regulation 870.3535 and is intended for single-use. Sterility and MRI safety specifications are not explicitly detailed in the provided data, but the device is regulated under the 510(k) clearance process (K980780) for cardiovascular applications.
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: Datascope Percor Stat-dl 9.5 Fr. 25, 34 and 40cc Intra-aoric Balloons ..., Datascope Percor Stat - Dl 9.5 Fr. 25 and 40cc Intra-aortic Balloon for ..., DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34... (K980780) - FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K980780 | Class II | Active |
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Manufacturer
- Manufacturer
- Datascope Corp.
Sources (1)
- FDA 510(k) K980780 24 fields · synced Sep 19, 2026