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FDA 510(k)

Selethru(TM) NC PTCA Balloon Dilatation Catheter

K-Number: K211393 · 2021-07-02

ApplicantKossel Medtech (Suzhou) Co., Ltd.
Decision Date2021-07-02
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Selethru(TM) NC PTCA Balloon Dilatation Catheter is a medical device manufactured by Kossel Medtech (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-07-02 under approval number K211393. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Selethru(TM) NC PTCA Balloon Dilatation Catheter?

Selethru(TM) NC PTCA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2021-07-02. It is manufactured by Kossel Medtech (Suzhou) Co., Ltd.. The 510(k) number is K211393.

When was Selethru(TM) NC PTCA Balloon Dilatation Catheter approved by the FDA?

Selethru(TM) NC PTCA Balloon Dilatation Catheter received FDA 510(k) clearance on 2021-07-02, under approval number K211393.

What company makes Selethru(TM) NC PTCA Balloon Dilatation Catheter?

Selethru(TM) NC PTCA Balloon Dilatation Catheter is manufactured by Kossel Medtech (Suzhou) Co., Ltd..

What is the FDA product code for Selethru(TM) NC PTCA Balloon Dilatation Catheter?

The FDA product code for Selethru(TM) NC PTCA Balloon Dilatation Catheter is LOX.

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 Kossel Medtech (Suzhou) Co., Ltd.

K182699Selethru PTCA Balloon Dilatation Catheter K221245PTA Balloon Dilatation Catheter K211349Selebrek PTCA Balloon Dilatation Catheter K231402HP PTA Balloon Dilatation Catheter

Related Devices (Code: LOX)

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation CatheteBoston Scientific Corporation K163174Emerge PTCA Dilatation CatheterBoston Scientific Corporation K160985Pantera ProBiotronik, Inc. K162209Sapphire NC PlusOrbusneich Medical, Inc. K153742Apollo Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited

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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