DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Dlp Retrograde Coronary Sinus Perfusion Cannula Without Pressure Monitoring Line, Dlp Retrograde Coronary Sinus Perfusio.

Pre-market Notification Details

• Device ID: K132995
• 510k Number: K132995
• Device Name: DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO
• Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• Applicant: MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428
• Contact: Chelsea Pioske
• Correspondent: Chelsea Pioske; MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428
• Product Code: DWF
• CFR Regulation Number: 870.4210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-09-24
• Decision Date: 2013-10-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20643169453177	K132995	000