Cardioblate CryoFlex Surgical Ablation System
K-Number: K191526 · 2019-10-01
ApplicantMedtronic, Inc.
Decision Date2019-10-01
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Cardioblate CryoFlex Surgical Ablation System is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2019-10-01 under approval number K191526. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cardioblate CryoFlex Surgical Ablation System?
Cardioblate CryoFlex Surgical Ablation System is a medical device that received FDA 510(k) clearance on 2019-10-01. It is manufactured by Medtronic, Inc.. The 510(k) number is K191526.
When was Cardioblate CryoFlex Surgical Ablation System approved by the FDA?
Cardioblate CryoFlex Surgical Ablation System received FDA 510(k) clearance on 2019-10-01, under approval number K191526.
What company makes Cardioblate CryoFlex Surgical Ablation System?
Cardioblate CryoFlex Surgical Ablation System is manufactured by Medtronic, Inc..
What is the FDA product code for Cardioblate CryoFlex Surgical Ablation System?
The FDA product code for Cardioblate CryoFlex Surgical Ablation System is OCL.
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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.