Identifiers
- 510(k) Number
- K172033 FDA 510(k)
- FDA Product Code
- LIT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pirouette High Pressure (HP) is a Catheter, Angioplasty, Peripheral, Transluminal. It is classified as a device with a regulation number of 870.1250 and a product code of LIT.
The device is supplied by Arravasc, Ltd. and has been authorized with an FDA 510K clearance. It is intended for use in the Cardiovascular medical specialty, with a device class of 2. The device has various registration numbers, including 3011471056, 3011142981, and 3027395815, and is used in accordance with its specifications and clearances.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172033 | Class II | Active |
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Manufacturer
- Manufacturer
- Arravasc, Ltd.
Sources (1)
- FDA 510(k) K172033 24 fields · synced Sep 23, 2026