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FDA 510(k)

D·Kaptain PTA High Pressure Balloon Dilatation Catheter

K-Number: K214009 · 2023-04-05

ApplicantDk Medical Technology Co., Ltd.
Decision Date2023-04-05
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

D·Kaptain PTA High Pressure Balloon Dilatation Catheter is a medical device manufactured by Dk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-04-05 under approval number K214009. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D·Kaptain PTA High Pressure Balloon Dilatation Catheter?

D·Kaptain PTA High Pressure Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2023-04-05. It is manufactured by Dk Medical Technology Co., Ltd.. The 510(k) number is K214009.

When was D·Kaptain PTA High Pressure Balloon Dilatation Catheter approved by the FDA?

D·Kaptain PTA High Pressure Balloon Dilatation Catheter received FDA 510(k) clearance on 2023-04-05, under approval number K214009.

What company makes D·Kaptain PTA High Pressure Balloon Dilatation Catheter?

D·Kaptain PTA High Pressure Balloon Dilatation Catheter is manufactured by Dk Medical Technology Co., Ltd..

What is the FDA product code for D·Kaptain PTA High Pressure Balloon Dilatation Catheter?

The FDA product code for D·Kaptain PTA High Pressure Balloon Dilatation Catheter is LIT.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT05147363 Shockwave: Disruption for A Better Fit WITHDRAWN NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)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

Other Devices by Dk Medical Technology Co., Ltd.

K232207D·Kutting™ PTA Scoring Balloon Dilatation Catheter K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter

Related Devices (Code: LIT)

K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K162316Pirouette 014Arravasc, Ltd. K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018Boston Scientific Corporation K161427Pirouette 035Arravasc Limited K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160004Crosstella OTWKANEKA Corporation

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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