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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 the device name listed in this FDA 510(k) record. The listed applicant is C2 Therapeutics, Inc.. It received FDA 510(k) clearance on 2016-04-13 under 510(k) 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. The listed applicant is C2 Therapeutics, Inc.. The 510(k) number is K152329.

When did Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System?

The FDA 510(k) record lists C2 Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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Other records listing C2 Therapeutics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163684C2 CryoBalloon Ablation SystemK161202C2 Cryoballoon Ablation SystemK160994C2 CryoBalloon Focal Pear CatheterK153541Coldplay CryoBalloon® Ablation System

Related Devices (Code: GEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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