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FDA 510(k)

Athletis PTA Balloon Dilatation Catheter

K-Number: K201170 · 2020-09-15

ApplicantBoston Scientific Corporation
Decision Date2020-09-15
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Athletis PTA Balloon Dilatation Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-09-15 under approval number K201170. 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 Athletis PTA Balloon Dilatation Catheter?

Athletis PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2020-09-15. It is manufactured by Boston Scientific Corporation. The 510(k) number is K201170.

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

Athletis PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2020-09-15, under approval number K201170.

What company makes Athletis PTA Balloon Dilatation Catheter?

Athletis PTA Balloon Dilatation Catheter is manufactured by Boston Scientific Corporation.

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

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

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Other Devices by Boston Scientific Corporation

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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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