CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE

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 68000 Gnerator, Bp2 Surgical Ablation Device, Lp Surgical Ablation Device, Gemini-ssurgical Ablation Device.

Pre-market Notification Details

• Device ID: K080509
• 510k Number: K080509
• Device Name: CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE
• Classification: Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
• Applicant: MEDTRONIC INC. 7601 NORTHLAND DRIVE Minneapolis, MN 55428
• Contact: Preeti Jain
• Correspondent: Preeti Jain; MEDTRONIC INC. 7601 NORTHLAND DRIVE Minneapolis, MN 55428
• Product Code: OCL
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-02-25
• Decision Date: 2008-05-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994759467	K080509	000
00643169121850	K080509	000
00721902070136	K080509	000