FDA 510(k)

Cardioblate CryoFlex Surgical Ablation System

K-Number: K191526 · 2019-10-01

Decision Date2019-10-01

Product CodeOCL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Cardioblate CryoFlex Surgical Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2019-10-01 under 510(k) 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. The listed applicant is Medtronic, Inc.. The 510(k) number is K191526.

When did Cardioblate CryoFlex Surgical Ablation System receive FDA 510(k) clearance?

Cardioblate CryoFlex Surgical Ablation System received FDA 510(k) clearance on 2019-10-01, under 510(k) number K191526.

Who is the listed applicant for Cardioblate CryoFlex Surgical Ablation System?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: OCL)

K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)AtriCure, Inc.K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation DeviceMedtronic, Inc.K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.

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.