G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS


Device Classification Name

filter, intravascular, cardiovascular

510(k) Number K080668
Device Name G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS
Applicant
C.R. BARD, INC.
1625 west 3rd st.
tempe, 
AZ 
85281 -1740

Applicant Contact genevieve balutowski
Correspondent
C.R. BARD, INC.
1625 west 3rd st.
tempe, 
AZ 
85281 -1740

Correspodent Contact genevieve balutowski
Regulation Number 870.3375
Classification Product Code
DTK  
Date Received 03/10/2008
Decision Date 07/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No