JOSTRA VENT CATHETERS, MODELS LV & HKV


Device Classification Name

catheter, cannula and tubing, vascular, cardiopulmonary bypass

510(k) Number K022022
Device Name JOSTRA VENT CATHETERS, MODELS LV & HKV
Original Applicant
JOSTRA AG
478 media rd.
oxford, 
PA 
19363

Original Contact kathleen johnson
Regulation Number 870.4210
Classification Product Code
DWF  
Subsequent Product Code
DRA  
Date Received 06/20/2002
Decision Date 09/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No