FDA 510(k)

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device

K-Number: K190623 · 2019-05-30

Decision Date2019-05-30

Product CodeOCL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2019-05-30 under 510(k) number K190623. 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 Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device?

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device is a medical device that received FDA 510(k) clearance on 2019-05-30. The listed applicant is Medtronic. The 510(k) number is K190623.

When did Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device receive FDA 510(k) clearance?

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device received FDA 510(k) clearance on 2019-05-30, under 510(k) number K190623.

Who is the listed applicant for Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device?

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

What is the FDA product code for Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device?

The FDA product code for Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device 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.