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FDA 510(k)

Tamarin Blue PTCA RX Dilatation Catheter

K-Number: K210012 · 2021-07-09

ApplicantNatec Medical , Ltd.
Decision Date2021-07-09
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tamarin Blue PTCA RX Dilatation Catheter is a medical device manufactured by Natec Medical , Ltd.. It received FDA 510(k) clearance on 2021-07-09 under approval number K210012. 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 Tamarin Blue PTCA RX Dilatation Catheter?

Tamarin Blue PTCA RX Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2021-07-09. It is manufactured by Natec Medical , Ltd.. The 510(k) number is K210012.

When was Tamarin Blue PTCA RX Dilatation Catheter approved by the FDA?

Tamarin Blue PTCA RX Dilatation Catheter received FDA 510(k) clearance on 2021-07-09, under approval number K210012.

What company makes Tamarin Blue PTCA RX Dilatation Catheter?

Tamarin Blue PTCA RX Dilatation Catheter is manufactured by Natec Medical , Ltd..

What is the FDA product code for Tamarin Blue PTCA RX Dilatation Catheter?

The FDA product code for Tamarin Blue PTCA RX Dilatation Catheter is LOX.

Related Clinical Trials

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Other Devices by Natec Medical , Ltd.

K220410Ebony HP PTA OTW 0.035 Catheter K241040Amethyst HP PTA OTW 0.035 Catheter K251915Amethyst HP PTA OTW 0.035 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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