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FDA 510(k)

Coldplay CryoBalloon® Ablation System

K-Number: K153541 · 2016-01-07

ApplicantC2 Therapeutics, Inc.
Decision Date2016-01-07
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Coldplay CryoBalloon® Ablation System is a medical device manufactured by C2 Therapeutics, Inc.. It received FDA 510(k) clearance on 2016-01-07 under approval number K153541. 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® Ablation System?

Coldplay CryoBalloon® Ablation System is a medical device that received FDA 510(k) clearance on 2016-01-07. It is manufactured by C2 Therapeutics, Inc.. The 510(k) number is K153541.

When was Coldplay CryoBalloon® Ablation System approved by the FDA?

Coldplay CryoBalloon® Ablation System received FDA 510(k) clearance on 2016-01-07, under approval number K153541.

What company makes Coldplay CryoBalloon® Ablation System?

Coldplay CryoBalloon® Ablation System is manufactured by C2 Therapeutics, Inc..

What is the FDA product code for Coldplay CryoBalloon® Ablation System?

The FDA product code for Coldplay CryoBalloon® Ablation System is GEH.

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Other Devices by C2 Therapeutics, Inc.

K160994C2 CryoBalloon Focal Pear Catheter K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System K161202C2 Cryoballoon Ablation System K163684C2 CryoBalloon Ablation System

Related Devices (Code: GEH)

K162695truFreeze SystemCSA Medical, Inc. K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical , Ltd. K161480R2 Dermal Cooling SystemR2 Dermatology K161294Compound W Wart Removal System Dual PowerMedtech Products, Inc. K161615AccurettH&O Equipments, Nv/Sa K161557truFreeze SystemCSA Medical, 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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