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FDA 510(k)

C2 CryoBalloon Focal Pear Catheter

K-Number: K160994 · 2016-05-19

ApplicantC2 Therapeutics, Inc.
Decision Date2016-05-19
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

C2 CryoBalloon Focal Pear Catheter is a medical device manufactured by C2 Therapeutics, Inc.. It received FDA 510(k) clearance on 2016-05-19 under approval number K160994. 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 Focal Pear Catheter?

C2 CryoBalloon Focal Pear Catheter is a medical device that received FDA 510(k) clearance on 2016-05-19. It is manufactured by C2 Therapeutics, Inc.. The 510(k) number is K160994.

When was C2 CryoBalloon Focal Pear Catheter approved by the FDA?

C2 CryoBalloon Focal Pear Catheter received FDA 510(k) clearance on 2016-05-19, under approval number K160994.

What company makes C2 CryoBalloon Focal Pear Catheter?

C2 CryoBalloon Focal Pear Catheter is manufactured by C2 Therapeutics, Inc..

What is the FDA product code for C2 CryoBalloon Focal Pear Catheter?

The FDA product code for C2 CryoBalloon Focal Pear Catheter is GEH.

Related Clinical Trials

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Other Devices by C2 Therapeutics, Inc.

K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System K153541Coldplay CryoBalloon® Ablation System K161202C2 Cryoballoon Ablation System K163684C2 CryoBalloon Ablation System

Related Devices (Code: 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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