RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET


information about

Device Classification Name

catheter, cannula and tubing, vascular, cardiopulmonary bypass

510(k) Number K002019
Device Name RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET
Original Applicant
CALIFORNIA MEDICAL LABORATORIES, INC.
2681 kelvin ave.
irvine, 
CA 
92614

Original Contact mehmet bicakci
Regulation Number 870.4210
Classification Product Code
DWF  
Date Received 07/03/2000
Decision Date 03/30/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No