FDA 510(k) clearance · back to tracker

Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System

C2 Therapeutics, Inc. cleared K151054 on 2015-07-07, decision: substantially equivalent

K-number

K151054

Sponsor

C2 Therapeutics, Inc.

Device

Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System

Class

Class II

Decision

Substantially Equivalent

Decision date

2015-07-07

Product code

GEH

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4350

Official FDA record

Open K151054on 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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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

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