FDA 510(k) clearance · back to tracker

C2 Cryoballoon Ablation System

C2 Therapeutics, Inc. cleared K161202 on 2017-01-05, decision: substantially equivalent

K-number

K161202

Sponsor

C2 Therapeutics, Inc.

Device

C2 Cryoballoon Ablation System

Class

Class II

Decision

Substantially Equivalent

Decision date

2017-01-05

Product code

GEH

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4350

Official FDA record

Open K161202on accessdata.fda.gov →

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

openFDA JSON

Raw record →

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.