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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 the device name listed in this FDA 510(k) record. The listed applicant is Medcaptain Life Science Co., Ltd.. It received FDA 510(k) clearance on 2021-05-06 under 510(k) 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. The listed applicant is Medcaptain Life Science Co., Ltd.. The 510(k) number is K202578.

When did KardiFlex NC Coronary Dilatation Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for KardiFlex NC Coronary Dilatation Catheter?

The FDA 510(k) record lists Medcaptain Life Science Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05509296Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery DiseaseCOMPLETED

Other records listing Medcaptain Life Science Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230528Extension SetK213004Needle Free ConnectorK202619KardiFlex PTCA Balloon Dilatation CatheterK202748Enteral Feeding Catheter

Related Devices (Code: LOX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261428NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic IrelandK261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic IrelandK252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.K252295RyureiTerumo CorporationK251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, Ireland

Official Source

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

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