French Intra-Aortic 9.5 Balloon On Kon
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K831397 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 French Intra-Aortic 9.5 Balloon On Kon is an intra-aortic balloon and control system, consisting of an inflatable balloon placed in the aorta to improve cardiovascular functioning during certain life-threatening situations. It is a prescription device. The device is substantially equivalent to other devices on the market.
The device is supplied in a size of 9.5 and is used in cardiovascular applications. It has been cleared by the FDA under the traditional clearance type with the k number K831397. The device is manufactured by Datascope Corp. and has a product code of DSP.
Frequently asked questions
What is the French Intra-Aortic 9.5 Balloon On Kon used for?
It is used in cardiovascular applications to improve functioning during certain life-threatening situations by placing an inflatable balloon in the aorta.
What size is the device supplied in?
The device is supplied in a size of 9.5.
Is the French Intra-Aortic 9.5 Balloon On Kon a prescription device?
Yes, it is a prescription device, indicating its use should be directed by a healthcare professional.
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: K831397 FDA 510(k) - FRENCH INTRA-AORTIC 9.5 BALLOON ON KON, FRENCH INTRA-AORTIC 9.5 BALLOON ON KON - Innolitics, French Intra-aortic 9.5 Balloon On Kon 510 (k) K831397 - FDA.report, PDF K831397 - French Intra-aortic 9.5 Balloon on Kon, Datascope'S 8fr. Alt B Iab; Datascope'S Profile 8fr. Alt B Iab ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K831397 | Class II | Active |
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Manufacturer
- Manufacturer
- Datascope Corp.
Sources (1)
- FDA 510(k) K831397 24 fields · synced Sep 25, 2026