SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Spherical Tip Coronary Ostial Cannula, Model 30011.

Pre-market Notification Details

• Device ID: K034058
• 510k Number: K034058
• Device Name: SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011
• Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• Applicant: MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428
• Contact: Preeti Jain
• Correspondent: Preeti Jain; MEDTRONIC VASCULAR 7611 NORTHLAND DR. 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: 2003-12-30
• Decision Date: 2004-01-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20613994737780	K034058	000