510(k) K043179

SELECT 3D ARTERIAL CANNULA by Medtronic Perfusion Systems — Product Code DWF

K043179 is an FDA 510(k) premarket notification submitted by Medtronic Perfusion Systems for the device "SELECT 3D ARTERIAL CANNULA". The FDA issued a decision of Substantially Equivalent on February 8, 2005. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Medtronic Perfusion Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2005
Date Received
November 17, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type