ViperCath XC Peripheral Exchange Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211251 FDA 510(k)
- FDA Product Code
- DQY 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 ViperCath XC Peripheral Exchange Catheter is a peripheral vascular catheter designed for guidewire exchange during interventional and diagnostic procedures. It facilitates the transition of guidewires up to 0.035" in diameter within peripheral arteries, supporting both straight and angled configurations for enhanced vascular access.
This catheter is supplied sterile for single-use in clinical settings, including interventional radiology and vascular surgery. It is authorised under FDA 510(k) clearance (K211251) and classified under product code DQY, adhering to regulatory standards for peripheral vascular devices. Storage and handling follow standard sterile medical device protocols.
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: DeviceMD - VIPERCATH™ XC PERIPHERAL EXCHANGE CATHETER, Vipercath XC Peripheral Exchange Catheter - Cardiovascular Systems ..., Peripheral Orbital Atherectomy Device Accessories | Abbott
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211251 | Class II | Active |
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Manufacturer
- Manufacturer
- Cardiovascular Systems, Inc.
Sources (1)
- FDA 510(k) K211251 24 fields · synced Sep 19, 2026