EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

MEDTRONIC PERFUSION SYSTEMS

The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Eopa Elongated One-piece Arterial Cannula And Guidewire.

Pre-market Notification Details

• Device ID: K031037
• 510k Number: K031037
• Device Name: EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE
• Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• Applicant: MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55428 -1088
• Contact: Ronald W Bennett
• Correspondent: Ronald W Bennett; MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55428 -1088
• Product Code: DWF
• CFR Regulation Number: 870.4210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-04-01
• Decision Date: 2003-05-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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20763000135625	K031037	000