Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KardiFlex NC Coronary Dilatation Catheter

K-Number: K202578 · 2021-05-06

ApplicantMedcaptain Life Science Co., Ltd.
Decision Date2021-05-06
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KardiFlex NC Coronary Dilatation Catheter is a medical device manufactured by Medcaptain Life Science Co., Ltd.. It received FDA 510(k) clearance on 2021-05-06 under approval number K202578. 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 NC Coronary Dilatation Catheter?

KardiFlex NC Coronary Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2021-05-06. It is manufactured by Medcaptain Life Science Co., Ltd.. The 510(k) number is K202578.

When was KardiFlex NC Coronary Dilatation Catheter approved by the FDA?

KardiFlex NC Coronary Dilatation Catheter received FDA 510(k) clearance on 2021-05-06, under approval number K202578.

What company makes KardiFlex NC Coronary Dilatation Catheter?

KardiFlex NC Coronary Dilatation Catheter is manufactured by Medcaptain Life Science Co., Ltd..

What is the FDA product code for KardiFlex NC Coronary Dilatation Catheter?

The FDA product code for KardiFlex NC Coronary Dilatation Catheter is LOX.

Related Clinical Trials

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 NCT06662500 FORWARD CAD IDE Study RECRUITING NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED NCT06795763 Acolyte CTO-PCI Study: Imaging and Catheter System to Treat Patients With Coronary Chronic Total Occlusion, Who Have Persistent Symptoms Following Medical Therapy and Are Undergoing Percutaneous Coronary Interventional Procedures ENROLLING_BY_INVITATION NCT05731700 CVT-ISR First in Human Trial for Coronary In-Stent Restenosis COMPLETED

Other Devices by Medcaptain Life Science Co., Ltd.

K202619KardiFlex PTCA Balloon 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.

↑