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FDA 510(k)

CRYOBALLOON FOCAL ABLATION SYSTEM

K-Number: K131523 · 2013-08-22

ApplicantC2 Therapeutics
Decision Date2013-08-22
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOBALLOON FOCAL ABLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is C2 Therapeutics. It received FDA 510(k) clearance on 2013-08-22 under 510(k) number K131523. 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 CRYOBALLOON FOCAL ABLATION SYSTEM?

CRYOBALLOON FOCAL ABLATION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-22. The listed applicant is C2 Therapeutics. The 510(k) number is K131523.

When did CRYOBALLOON FOCAL ABLATION SYSTEM receive FDA 510(k) clearance?

CRYOBALLOON FOCAL ABLATION SYSTEM received FDA 510(k) clearance on 2013-08-22, under 510(k) number K131523.

Who is the listed applicant for CRYOBALLOON FOCAL ABLATION SYSTEM?

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

What is the FDA product code for CRYOBALLOON FOCAL ABLATION SYSTEM?

The FDA product code for CRYOBALLOON FOCAL ABLATION SYSTEM is GEH.

Related Clinical Trials

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.

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Other records listing C2 Therapeutics 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.

K101825CRYOBALLOON 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.

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex MedicalK261068Maverix 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.

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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