EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE


the company

Device Classification Name

catheter, cannula and tubing, vascular, cardiopulmonary bypass

510(k) Number K000274
Device Name EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE
Original Applicant
MEDTRONIC CARDIAC SURGICAL PRODUCTS
620 watson s.w.
grand rapids, 
MI 
49504

Original Contact james balun
Regulation Number 870.4210
Classification Product Code
DWF  
Date Received 01/31/2000
Decision Date 02/10/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No