Powercross .018 OTW PTA Dilation Catheter
FDA 510(k)Class II (US FDA 510(k))
by Ev3, Inc
Identifiers
- 510(k) Number
- K093286 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)
This device is a catheter, angioplasty, peripheral, transluminal, as defined by its device type and nomenclature. It is designed for percutaneous transluminal angioplasty (PTA) procedures to dilate narrowed or obstructed peripheral blood vessels.
The catheter is supplied in a sterile condition for single-use only. It is authorized under FDA 510(k) clearance (K093286) and is intended for use in cardiovascular interventional settings. No information regarding MRI safety, specific sizes, or storage conditions is provided in the data.
Frequently asked questions
What is the POWERCROSS .018 OTW PTA DILATION CATHETER used for?
This catheter is designed for percutaneous transluminal angioplasty (PTA) procedures to dilate narrowed or obstructed peripheral blood vessels in cardiovascular interventional settings.
Is the POWERCROSS .018 OTW PTA DILATION CATHETER reusable or single-use?
The catheter is supplied in a sterile condition for single-use only, meaning it should be discarded after one procedure to ensure patient safety and device performance.
What regulatory authorization does the POWERCROSS .018 OTW PTA DILATION CATHETER have?
The device is authorized under FDA 510(k) clearance (K093286) as substantially equivalent to other marketed devices of the same type for its intended use in cardiovascular procedures.
What information is available about the sizes and models of the POWERCROSS .018 OTW PTA DILATION CATHETER?
The device data does not provide specific information about available sizes or models beyond the .018 OTW (over-the-wire) designation, which indicates its compatibility with guidewires for navigation through vessels.
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 | K093286 | Class II | Active |
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Manufacturer
- Manufacturer
- Ev3, Inc
- FDA Applicant
- Ev3, Inc.
Sources (1)
- FDA 510(k) K093286 24 fields · synced Sep 21, 2026