510(k) K000776

MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP by Medtronic Cardiac Surgical Products — Product Code DWF

K000776 is an FDA 510(k) premarket notification submitted by Medtronic Cardiac Surgical Products for the device "MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP". The FDA issued a decision of Substantially Equivalent on February 7, 2001. 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 Cardiac Surgical Products has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2001
Date Received
March 10, 2000
Clearance Type
Traditional
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