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FDA 510(k)

D·Kutting™ PTA Scoring Balloon Dilatation Catheter

K-Number: K232207 · 2024-03-07

ApplicantDk Medical Technology Co., Ltd.
Decision Date2024-03-07
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

D·Kutting™ PTA Scoring Balloon Dilatation Catheter is a medical device manufactured by Dk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-03-07 under approval number K232207. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D·Kutting™ PTA Scoring Balloon Dilatation Catheter?

D·Kutting™ PTA Scoring Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2024-03-07. It is manufactured by Dk Medical Technology Co., Ltd.. The 510(k) number is K232207.

When was D·Kutting™ PTA Scoring Balloon Dilatation Catheter approved by the FDA?

D·Kutting™ PTA Scoring Balloon Dilatation Catheter received FDA 510(k) clearance on 2024-03-07, under approval number K232207.

What company makes D·Kutting™ PTA Scoring Balloon Dilatation Catheter?

D·Kutting™ PTA Scoring Balloon Dilatation Catheter is manufactured by Dk Medical Technology Co., Ltd..

What is the FDA product code for D·Kutting™ PTA Scoring Balloon Dilatation Catheter?

The FDA product code for D·Kutting™ PTA Scoring Balloon Dilatation Catheter is PNO.

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 Dk Medical Technology Co., Ltd.

K214009D·Kaptain PTA High Pressure Balloon Dilatation Catheter K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter

Related Devices (Code: PNO)

K152789FLEX SCORING CATHETERVenturemed Group K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc. K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc. K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC

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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