Cardioblate CryoFlex Surgical Ablation System

Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Cardioblate Cryoflex Surgical Ablation System.

Pre-market Notification Details

• Device ID: K191526
• 510k Number: K191526
• Device Name: Cardioblate CryoFlex Surgical Ablation System
• Classification: Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
• Applicant: Medtronic, Inc. 3800 Annapolis Lane Plymouth, MN 55447
• Contact: Choua Thao
• Correspondent: Choua Thao; Medtronic, Inc. 3800 Annapolis Lane Plymouth, MN 55447
• Product Code: OCL
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-06-10
• Decision Date: 2019-10-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169983069	K191526	000
00643169983045	K191526	000
00643169983038	K191526	000
00643169983052	K191526	000