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FDA 510(k)

Serranator PTA Serration Balloon Catheter

K-Number: K203437 · 2020-12-22

ApplicantCagent Vascular, LLC
Decision Date2020-12-22
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Serranator PTA Serration Balloon Catheter is a medical device manufactured by Cagent Vascular, LLC. It received FDA 510(k) clearance on 2020-12-22 under approval number K203437. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Serranator PTA Serration Balloon Catheter?

Serranator PTA Serration Balloon Catheter is a medical device that received FDA 510(k) clearance on 2020-12-22. It is manufactured by Cagent Vascular, LLC. The 510(k) number is K203437.

When was Serranator PTA Serration Balloon Catheter approved by the FDA?

Serranator PTA Serration Balloon Catheter received FDA 510(k) clearance on 2020-12-22, under approval number K203437.

What company makes Serranator PTA Serration Balloon Catheter?

Serranator PTA Serration Balloon Catheter is manufactured by Cagent Vascular, LLC.

What is the FDA product code for Serranator PTA Serration Balloon Catheter?

The FDA product code for Serranator PTA Serration Balloon Catheter is PNO.

Related Clinical Trials

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Other Devices by Cagent Vascular, LLC

K163380Serranator Alto PTA Serration Balloon Catheter K193181Serranator PTA Serration Balloon Catheter K213728Serranator PTA Serration Balloon Catheter K220704Serranator PTA Serration Balloon Catheter

Related Devices (Code: PNO)

K152789FLEX SCORING CATHETERVenturemed Group K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc. K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc. K202187FLEX Vessel Prep SystemVenturemed Group, Inc.

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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