LV-1 HEMOSTASIS VALVE, MODEL #6789


Device Classification Name

adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

510(k) Number K021282
Device Name LV-1 HEMOSTASIS VALVE, MODEL #6789
Original Applicant
GUIDANT CORP.
4100 hamline ave., north
st. paul, 
MN 
55112 -5798

Original Contact karen s alsop
Regulation Number 870.4290
Classification Product Code
DTL  
Date Received 04/18/2002
Decision Date 05/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No