C2 Cryoballoon Ablation System
K-Number: K161202 · 2017-01-05
ApplicantC2 Therapeutics, Inc.
Decision Date2017-01-05
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
C2 Cryoballoon Ablation System is a medical device manufactured by C2 Therapeutics, Inc.. It received FDA 510(k) clearance on 2017-01-05 under approval number K161202. 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 C2 Cryoballoon Ablation System?
C2 Cryoballoon Ablation System is a medical device that received FDA 510(k) clearance on 2017-01-05. It is manufactured by C2 Therapeutics, Inc.. The 510(k) number is K161202.
When was C2 Cryoballoon Ablation System approved by the FDA?
C2 Cryoballoon Ablation System received FDA 510(k) clearance on 2017-01-05, under approval number K161202.
What company makes C2 Cryoballoon Ablation System?
C2 Cryoballoon Ablation System is manufactured by C2 Therapeutics, Inc..
What is the FDA product code for C2 Cryoballoon Ablation System?
The FDA product code for C2 Cryoballoon Ablation System is GEH.
Related Clinical Trials
NCT07137455
EDEN Intracardiac Electrogram Recording and Classifying System
ENROLLING_BY_INVITATION
NCT06762717
FARAPULSE™ Pulsed Field Ablation System
RECRUITING
NCT06170606
POLARx Post Approval Study (POLARx PAS)
ACTIVE_NOT_RECRUITING
NCT06510556
Feasibility Study of the FARAFLEX Mapping and PFA System
RECRUITING
NCT06735534
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
RECRUITING
NCT07523620
Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration
RECRUITING
Other Devices by C2 Therapeutics, Inc.
Related Devices (Code: GEH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.