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FDA 510(k)

Artimes pro Balloon Dilatation Catheter

K-Number: K203390 · 2021-04-14

ApplicantBrosmed Medical Co., Ltd.
Decision Date2021-04-14
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Artimes pro Balloon Dilatation Catheter is a medical device manufactured by Brosmed Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-04-14 under approval number K203390. 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 Artimes pro Balloon Dilatation Catheter?

Artimes pro Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2021-04-14. It is manufactured by Brosmed Medical Co., Ltd.. The 510(k) number is K203390.

When was Artimes pro Balloon Dilatation Catheter approved by the FDA?

Artimes pro Balloon Dilatation Catheter received FDA 510(k) clearance on 2021-04-14, under approval number K203390.

What company makes Artimes pro Balloon Dilatation Catheter?

Artimes pro Balloon Dilatation Catheter is manufactured by Brosmed Medical Co., Ltd..

What is the FDA product code for Artimes pro Balloon Dilatation Catheter?

The FDA product code for Artimes pro Balloon Dilatation Catheter is LOX.

Related Clinical Trials

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Other Devices by Brosmed Medical Co., Ltd.

K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter K153742Apollo Balloon Dilatation Catheter K160256Polux , Minerva and Atropos PTA Balloon Dilatation Catheter K212215Tiche PTA Balloon Dilatation Catheter K230705POT PTCA Balloon Dilatation Catheter K241478Tri-Wedge PTA Scoring Balloon Dilatation Catheter

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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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