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FDA 510(k)

NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter

K-Number: K222538 · 2022-12-21

ApplicantSino Medical Sciences Technology, Inc.
Decision Date2022-12-21
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is a medical device manufactured by Sino Medical Sciences Technology, Inc.. It received FDA 510(k) clearance on 2022-12-21 under approval number K222538. 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 NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter?

NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-12-21. It is manufactured by Sino Medical Sciences Technology, Inc.. The 510(k) number is K222538.

When was NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter approved by the FDA?

NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter received FDA 510(k) clearance on 2022-12-21, under approval number K222538.

What company makes NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter?

NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is manufactured by Sino Medical Sciences Technology, Inc..

What is the FDA product code for NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter?

The FDA product code for NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is LOX.

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 Sino Medical Sciences Technology, Inc.

K223022SC HONKYTONK PTCA Balloon Dilatation Catheter

Related Devices (Code: LOX)

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation CatheteBoston Scientific Corporation K163174Emerge PTCA Dilatation CatheterBoston Scientific Corporation K160985Pantera ProBiotronik, Inc. K162209Sapphire NC PlusOrbusneich Medical, Inc. K153742Apollo Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited

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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