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FDA 510(k)

Tiche PTA Balloon Dilatation Catheter

K-Number: K212215 · 2022-07-19

ApplicantBrosmed Medical Co., Ltd.
Decision Date2022-07-19
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tiche PTA Balloon Dilatation Catheter is a medical device manufactured by Brosmed Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-07-19 under approval number K212215. 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 Tiche PTA Balloon Dilatation Catheter?

Tiche PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-07-19. It is manufactured by Brosmed Medical Co., Ltd.. The 510(k) number is K212215.

When was Tiche PTA Balloon Dilatation Catheter approved by the FDA?

Tiche PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2022-07-19, under approval number K212215.

What company makes Tiche PTA Balloon Dilatation Catheter?

Tiche PTA Balloon Dilatation Catheter is manufactured by Brosmed Medical Co., Ltd..

What is the FDA product code for Tiche PTA Balloon Dilatation Catheter?

The FDA product code for Tiche PTA Balloon Dilatation Catheter is LIT.

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 K203390Artimes pro Balloon Dilatation Catheter K230705POT PTCA Balloon Dilatation Catheter K241478Tri-Wedge PTA Scoring Balloon Dilatation Catheter

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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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