FDA 510(k) clearance · back to tracker

Coldplay CryoBalloon® Ablation System

C2 Therapeutics, Inc. cleared K153541 on 2016-01-07, decision: substantially equivalent

K-number

K153541

Sponsor

C2 Therapeutics, Inc.

Device

Coldplay CryoBalloon® Ablation System

Class

Class II

Decision

Substantially Equivalent

Decision date

2016-01-07

Product code

GEH

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4350

Official FDA record

Open K153541on 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.