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FDA 510(k)

Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System

K-Number: K152329 · 2016-04-13

ApplicantC2 Therapeutics, Inc.
Decision Date2016-04-13
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System is a medical device manufactured by C2 Therapeutics, Inc.. It received FDA 510(k) clearance on 2016-04-13 under approval number K152329. 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 Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System?

Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System is a medical device that received FDA 510(k) clearance on 2016-04-13. It is manufactured by C2 Therapeutics, Inc.. The 510(k) number is K152329.

When was Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System approved by the FDA?

Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System received FDA 510(k) clearance on 2016-04-13, under approval number K152329.

What company makes Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System?

Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System is manufactured by C2 Therapeutics, Inc..

What is the FDA product code for Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System?

The FDA product code for Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System is GEH.

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Other Devices by C2 Therapeutics, Inc.

K160994C2 CryoBalloon Focal Pear Catheter K153541Coldplay CryoBalloon® Ablation System K161202C2 Cryoballoon Ablation System K163684C2 CryoBalloon Ablation System

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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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