FDA 510(k) clearance · back to tracker

C2 CryoBalloon Ablation System

C2 Therapeutics, Inc. cleared K163684 on 2018-01-23, decision: substantially equivalent

K-number

K163684

Sponsor

C2 Therapeutics, Inc.

Device

C2 CryoBalloon Ablation System

Class

Class II

Decision

Substantially Equivalent

Decision date

2018-01-23

Product code

GEH

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4350

Official FDA record

Open K163684on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.