510(k) K052372

MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C by Medtronic Perfusion Systems — Product Code DWF

K052372 is an FDA 510(k) premarket notification submitted by Medtronic Perfusion Systems for the device "MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C". The FDA issued a decision of Substantially Equivalent on September 22, 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
September 22, 2005
Date Received
August 30, 2005
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