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Aperta NSE PTA Balloon Dilatation Catheter (AA18-05040040)

by Goodman Co., Ltd.

510(k) K232013

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 · Traditional NumberK232013 Date28 Mar 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
PNO
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

The Aperta NSE PTA Balloon Dilatation Catheter is a percutaneous transluminal angioplasty (PTA) device indicated for the treatment of lesions in peripheral arteries, including iliac, femoral, popliteal and infra-popliteal arteries, and for obstructive lesions of native or synthetic arteriovenous dialysis fistulae. It is also indicated for the treatment of in-stent restenosis of balloon-expandable stents.

This catheter is supplied in various model numbers including AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040, AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, and AW18-14580040. The device has received FDA 510(k) clearance with product code PNO and is classified as a Class II device.

Other devices from Goodman Co., Ltd.

Questions

AI-generated answers, 24 Sep 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 Aperta NSE PTA Balloon Dilatation Catheter used for?

    The Aperta NSE PTA Balloon Dilatation Catheter is indicated for treating lesions in peripheral arteries including iliac, femoral, popliteal and infra-popliteal arteries, as well as obstructive lesions in native or synthetic arteriovenous dialysis fistulae and in-stent restenosis of balloon-expandable stents.

  • What models are available for the Aperta NSE PTA Balloon Dilatation Catheter?

    The catheter is supplied in various model numbers including AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040, AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, and AW18-14580040.

  • What is the regulatory status of the Aperta NSE PTA Balloon Dilatation Catheter?

    The device has received FDA 510(k) clearance with product code PNO and is classified as a Class II device. It was cleared through the traditional pathway with a decision code of SESE (Substantially Equivalent) on March 28, 2024.

  • Is the Aperta NSE PTA Balloon Dilatation Catheter single-use or reusable?

    The device data does not specify whether the Aperta NSE PTA Balloon Dilatation Catheter is designed for single-use or multiple uses. This information would typically be found in the device's instructions for use, which are not provided in the available data.