Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OsteoCool V-3 RF Ablation System

K-Number: K161949 · 2017-01-31

ApplicantBaylis Medical Company, Inc.
Decision Date2017-01-31
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OsteoCool V-3 RF Ablation System is a medical device manufactured by Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2017-01-31 under approval number K161949. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsteoCool V-3 RF Ablation System?

OsteoCool V-3 RF Ablation System is a medical device that received FDA 510(k) clearance on 2017-01-31. It is manufactured by Baylis Medical Company, Inc.. The 510(k) number is K161949.

When was OsteoCool V-3 RF Ablation System approved by the FDA?

OsteoCool V-3 RF Ablation System received FDA 510(k) clearance on 2017-01-31, under approval number K161949.

What company makes OsteoCool V-3 RF Ablation System?

OsteoCool V-3 RF Ablation System is manufactured by Baylis Medical Company, Inc..

What is the FDA product code for OsteoCool V-3 RF Ablation System?

The FDA product code for OsteoCool V-3 RF Ablation System is GEI.

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 Baylis Medical Company, Inc.

K161878PORTAGE System K191546Epicardial Access System K183632Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable K183649Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable K183655VersaCross Transseptal Sheath K190688VersaCross Steerable Sheath, VersaCross Transseptal Dilator

View all 18 devices →

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.

↑