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FDA 510(k)

D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter

K-Number: K242254 · 2025-04-21

ApplicantDk Medical Technology Co., Ltd.
Decision Date2025-04-21
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter is a medical device manufactured by Dk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-21 under approval number K242254. 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™ LL Peripheral Scoring Balloon Dilatation Catheter?

D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2025-04-21. It is manufactured by Dk Medical Technology Co., Ltd.. The 510(k) number is K242254.

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

D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter received FDA 510(k) clearance on 2025-04-21, under approval number K242254.

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

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

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

The FDA product code for D·Kutting™ LL Peripheral 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 K232207D·Kutting™ PTA 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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