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FDA 510(k)

Aperta NSE PTA Balloon Dilatation Catheter

K-Number: K243944 · 2025-04-22

ApplicantGoodman Co., Ltd.
Decision Date2025-04-22
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aperta NSE PTA Balloon Dilatation Catheter is a medical device manufactured by Goodman Co., Ltd.. It received FDA 510(k) clearance on 2025-04-22 under approval number K243944. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aperta NSE PTA Balloon Dilatation Catheter?

Aperta NSE PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2025-04-22. It is manufactured by Goodman Co., Ltd.. The 510(k) number is K243944.

When was Aperta NSE PTA Balloon Dilatation Catheter approved by the FDA?

Aperta NSE PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2025-04-22, under approval number K243944.

What company makes Aperta NSE PTA Balloon Dilatation Catheter?

Aperta NSE PTA Balloon Dilatation Catheter is manufactured by Goodman Co., Ltd..

What is the FDA product code for Aperta NSE PTA Balloon Dilatation Catheter?

The FDA product code for Aperta NSE PTA Balloon Dilatation Catheter is PNO.

Related Clinical Trials

NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_RECRUITING NCT06492174 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort ACTIVE_NOT_RECRUITING NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING NCT07414771 Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP) NOT_YET_RECRUITING NCT07587541 Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter NOT_YET_RECRUITING

Other Devices by Goodman Co., Ltd.

K232013Aperta 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, AW18-14580040) PMA P230026Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

Related Devices (Code: PNO)

K152789FLEX SCORING CATHETERVenturemed Group K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc. K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc. K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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