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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 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 2021-04-29 under 510(k) 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. The listed applicant is Medcaptain Life Science Co., Ltd.. The 510(k) number is K202619.

When did KardiFlex PTCA Balloon Dilatation Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for KardiFlex PTCA Balloon 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 PTCA Balloon Dilatation Catheter?

The FDA product code for KardiFlex PTCA Balloon 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.

NCT04058990Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)COMPLETEDNCT04647253A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)ACTIVE_NOT_RECRUITINGNCT05509296Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery DiseaseCOMPLETEDNCT06492174A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion CohortACTIVE_NOT_RECRUITINGNCT06832631VITUS Post-Market RegistryACTIVE_NOT_RECRUITINGNCT07397390an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified LesionsENROLLING_BY_INVITATION

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 ConnectorK202578KardiFlex NC Coronary 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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