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Ebony PTA .014 RX Peripheral Dilatation Catheter

by Natec Medical

510(k) K152230

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK152230 Date3 Sep 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1362-2016 FDA Class II initiated 11 Feb 2016

    Product may kink during use rendering the product unusable.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Ebony PTA .014 RX Pheripheral Dilatation Catheter
510(k) Number
FDA Product Code
LIT
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ebony PTA .014 RX Peripheral Dilatation Catheter is a percutaneous transluminal angioplasty (PTA) catheter designed for the dilatation of peripheral arterial lesions. It is intended for use in the iliac, femoral, popliteal, infra-popliteal, and renal arteries to restore blood flow by mechanically widening narrowed or obstructed segments. Constructed for precision, this catheter features a .014-inch outer diameter, enabling navigation through smaller vessels while delivering controlled dilation via an inflatable balloon.

This device is supplied as a single-use, non-sterile catheter requiring terminal sterilization prior to use. It is classified as a Class II medical device under FDA regulations (870.1250) and has received FDA 510(k) clearance (K152230) as substantially equivalent to predicate devices. The catheter is available in various balloon sizes and lengths, including diameters up to 1.5 mm and lengths up to 200 mm, to accommodate different clinical scenarios. Compatibility with imaging modalities, including MRI safety considerations, is not specified in the regulatory data.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Ebony PTA .014 RX Peripheral Dilatation Catheter used for?

    This catheter is designed specifically for percutaneous transluminal angioplasty (PTA) to mechanically widen narrowed or obstructed segments in peripheral arteries. It is intended for use in the iliac, femoral, popliteal, infra-popliteal, and renal arteries to restore blood flow by controlled dilation via an inflatable balloon. Its .014-inch outer diameter allows navigation through smaller vessels, making it suitable for precise interventions in tight or complex anatomical areas.

  • How is the Ebony PTA .014 RX catheter supplied, and what sterilization is required?

    The catheter is supplied as a single-use, non-sterile device. Terminal sterilization must be performed prior to use, as it is not pre-sterilized by the manufacturer. This ensures safety and efficacy for each procedure, as single-use devices are not intended for reuse.

  • What balloon sizes and lengths are available for the Ebony PTA .014 RX catheter?

    The catheter is available in various balloon sizes and lengths to accommodate different clinical scenarios. Balloon diameters range up to 1.5 mm, and lengths extend up to 200 mm. These options allow clinicians to select the appropriate size for the specific arterial segment being treated, ensuring optimal dilation and minimal trauma to the vessel wall.

  • Is the Ebony PTA .014 RX catheter compatible with imaging modalities like MRI?

    The regulatory data for this device does not specify compatibility with imaging modalities such as MRI. Clinicians should verify compatibility with their specific imaging equipment and protocols before use, particularly if MRI safety is a concern in the procedure.

  • What regulatory clearance does the Ebony PTA .014 RX catheter hold, and how is it classified?

    The Ebony PTA .014 RX Peripheral Dilatation Catheter is classified as a Class II medical device under FDA regulations (870.1250). It has received FDA 510(k) clearance (K152230) as substantially equivalent to predicate devices, indicating it meets the necessary safety and effectiveness standards for marketing in the United States.