RapidCross PTA Rapid Exchange Balloon Dilatation Catheter
FDA 510(k)Class II (US FDA 510(k))
by Ev3, Inc
Identifiers
- 510(k) Number
- K123544 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 RapidCross PTA Rapid Exchange Balloon Dilatation Catheter is a rapid exchange coaxial catheter designed for peripheral angioplasty. It features a semi-compliant, distally mounted balloon intended to dilate stenoses in peripheral arteries, including the iliac, femoral, ilio-femoral, popliteal, and infrapopliteal vessels. The device is compatible with 0.014-inch guidewires and incorporates an atraumatic, tapered tip for enhanced navigability.
This catheter is supplied as a single-use, non-sterile device requiring terminal sterilization prior to use. It is compatible with standard fluoroscopic imaging and is intended for use in interventional radiology and cardiology settings. The device includes a lubricious distal coating and a manifold with an inflation lumen for balloon inflation and deflation. Authorized under FDA 510(k) clearance (K123544), it adheres to regulatory standards for Class II medical devices (870.1250)
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: RapidCross™ RX PTA catheter - Medtronic, PDF MAY 2 A 2813 - Food and Drug Administration, RapidCross™ RX PTA catheter - Medtronic (Europe)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123544 | Class II | Active |
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Manufacturer
- Manufacturer
- Ev3, Inc
- FDA Applicant
- Ev3, Inc.
Sources (1)
- FDA 510(k) K123544 24 fields · synced Sep 19, 2026