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FDA 510(k)

KardiFlex PTCA Balloon Dilatation Catheter

K-Number: K202619 · 2021-04-29

ApplicantMedcaptain Life Science Co., Ltd.
Decision Date2021-04-29
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KardiFlex PTCA Balloon Dilatation Catheter is a medical device manufactured by Medcaptain Life Science Co., Ltd.. It received FDA 510(k) clearance on 2021-04-29 under approval number K202619. 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 KardiFlex PTCA Balloon Dilatation Catheter?

KardiFlex PTCA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2021-04-29. It is manufactured by Medcaptain Life Science Co., Ltd.. The 510(k) number is K202619.

When was KardiFlex PTCA Balloon Dilatation Catheter approved by the FDA?

KardiFlex PTCA Balloon Dilatation Catheter received FDA 510(k) clearance on 2021-04-29, under approval number K202619.

What company makes KardiFlex PTCA Balloon Dilatation Catheter?

KardiFlex PTCA Balloon Dilatation Catheter is manufactured by Medcaptain Life Science Co., Ltd..

What is the FDA product code for KardiFlex PTCA Balloon Dilatation Catheter?

The FDA product code for KardiFlex 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 Medcaptain Life Science Co., Ltd.

K202578KardiFlex NC Coronary Dilatation Catheter K202748Enteral Feeding Catheter K213004Needle Free Connector K230528Extension Set

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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