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FDA 510(k)

Mozec NC-Rx PTCA Baloon Dilatation Catheter

K-Number: K160961 · 2016-07-30

ApplicantMeril Life Sciences Private Limited
Decision Date2016-07-30
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Mozec NC-Rx PTCA Baloon Dilatation Catheter is a medical device manufactured by Meril Life Sciences Private Limited. It received FDA 510(k) clearance on 2016-07-30 under approval number K160961. 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 Mozec NC-Rx PTCA Baloon Dilatation Catheter?

Mozec NC-Rx PTCA Baloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2016-07-30. It is manufactured by Meril Life Sciences Private Limited. The 510(k) number is K160961.

When was Mozec NC-Rx PTCA Baloon Dilatation Catheter approved by the FDA?

Mozec NC-Rx PTCA Baloon Dilatation Catheter received FDA 510(k) clearance on 2016-07-30, under approval number K160961.

What company makes Mozec NC-Rx PTCA Baloon Dilatation Catheter?

Mozec NC-Rx PTCA Baloon Dilatation Catheter is manufactured by Meril Life Sciences Private Limited.

What is the FDA product code for Mozec NC-Rx PTCA Baloon Dilatation Catheter?

The FDA product code for Mozec NC-Rx PTCA Baloon Dilatation Catheter is LOX.

Related Clinical Trials

NCT07397390 an 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 Lesions ENROLLING_BY_INVITATION NCT05509296 Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease COMPLETED

Other Devices by Meril Life Sciences Private Limited

K181023Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter K190619Aspiron(TM) Aspiration 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. K153682Chocolate XD PTCA Balloon CatheterTrireme Medical, 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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