CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880

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

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Cardioblate Surgical Ablation Pen, Model 60811c; Cardioblate Surgical Ablation Generator, Model 60880.

Pre-market Notification Details

• Device ID: K013392
• 510k Number: K013392
• Device Name: CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880
• Classification: Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
• Applicant: MEDTRONIC VASCULAR 1015 GRAMSIE RD Shoreview, MN 55126 -3082
• Contact: Scott Candy
• Correspondent: Scott Candy; MEDTRONIC VASCULAR 1015 GRAMSIE RD Shoreview, MN 55126 -3082
• Product Code: OCL
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-10-15
• Decision Date: 2002-01-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00721902709340	K013392	000