Aperta NSE PTA Balloon Dilatation Catheter (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, AW18-14

FDA 510(k) K232013 · Goodman Co., Ltd.

Substantially Equivalent

510(k) numberK232013

Submission

Device name
Aperta NSE PTA Balloon Dilatation Catheter (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, AW18-14
Applicant
Goodman Co., Ltd.
Nagoya, JP
Received
July 6, 2023
Decision date
March 28, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PNO – Catheter, Percutaneous, Cutting/Scoring
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Specialty
Cardiovascular

To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material

Other 510(k)s with product code PNO

510(k)DeviceApplicantDecision
K260012UltraScore™ Focused Force PTA BalloonPNO · Special Bard Peripheral Vascular, Inc.02/04/2026SE
K243944Aperta NSE PTA Balloon Dilatation CatheterPNO · Traditional Goodman Co., Ltd.04/22/2025SE
K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterPNO · Traditional Dk Medical Technology Co., Ltd.04/21/2025SE
K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterPNO · Traditional Brosmed Medical Co., Ltd.10/22/2024SE
K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterPNO · Traditional Transit Scientific, LLC06/17/2024SE
K232207D·Kutting™ PTA Scoring Balloon Dilatation CatheterPNO · Traditional Dk Medical Technology Co., Ltd.03/07/2024SE
K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterPNO · Special Transit Scientific, LLC10/18/2022SE
K220704Serranator PTA Serration Balloon CatheterPNO · Traditional Cagent Vascular, LLC05/04/2022SE
K213728Serranator PTA Serration Balloon CatheterPNO · Special Cagent Vascular, LLC12/15/2021SE
K203437Serranator PTA Serration Balloon CatheterPNO · Special Cagent Vascular, LLC12/22/2020SE

More from Cagent Vascular, LLC

510(k)DeviceDecision
K243944Aperta NSE PTA Balloon Dilatation CatheterPNO · Traditional 04/22/2025SE
K010763GoodnetLLZ · Traditional 05/25/2001SE

Questions and answers

When was Aperta NSE PTA Balloon Dilatation Catheter (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, AW18-14 cleared by the FDA?

Aperta NSE PTA Balloon Dilatation Catheter (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, AW18-14 (K232013) received a 510(k) decision of Substantially Equivalent on March 28, 2024, 266 days after the submission was received.

What is the product code of K232013?

The FDA product code is PNO – Catheter, Percutaneous, Cutting/Scoring, a Class II (moderate risk) device regulated under 21 CFR 870.1250.