MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

MEDTRONIC CARDIAC SURGICAL PRODUCTS

The following data is part of a premarket notification filed by Medtronic Cardiac Surgical Products with the FDA for Medtronic Aortocoronary Shunt And Separately Packaged Arteriotomy Cannulae.

Pre-market Notification Details

• Device ID: K994171
• 510k Number: K994171
• Device Name: MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE
• Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• Applicant: MEDTRONIC CARDIAC SURGICAL PRODUCTS 620 WATSON S.W. Grand Rapids, MI 49504
• Contact: James Balun
• Correspondent: James Balun; MEDTRONIC CARDIAC SURGICAL PRODUCTS 620 WATSON S.W. Grand Rapids, MI 49504
• Product Code: DWF
• CFR Regulation Number: 870.4210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-12-10
• Decision Date: 2000-04-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20613994578956	K994171	000
20613994578949	K994171	000
20613994578932	K994171	000