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FDA 510(k)

C2 CryoBalloon Ablation System

K-Number: K212814 · 2021-11-29

ApplicantPentax of America, Inc.
Decision Date2021-11-29
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

C2 CryoBalloon Ablation System is a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2021-11-29 under approval number K212814. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C2 CryoBalloon Ablation System?

C2 CryoBalloon Ablation System is a medical device that received FDA 510(k) clearance on 2021-11-29. It is manufactured by Pentax of America, Inc.. The 510(k) number is K212814.

When was C2 CryoBalloon Ablation System approved by the FDA?

C2 CryoBalloon Ablation System received FDA 510(k) clearance on 2021-11-29, under approval number K212814.

What company makes C2 CryoBalloon Ablation System?

C2 CryoBalloon Ablation System is manufactured by Pentax of America, Inc..

What is the FDA product code for C2 CryoBalloon Ablation System?

The FDA product code for C2 CryoBalloon Ablation System is GEH.

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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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