MERIDIAN FILTER SYSTEM – FEMORAL DELIVERY KIT


Device Classification Name

filter, intravascular, cardiovascular

510(k) Number K112497
Device Name MERIDIAN FILTER SYSTEM – FEMORAL DELIVERY KIT
Applicant
C.R. BARD, INC.
1625 west 3rd st.
tempe, 
AZ 
85281 -1740

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

Correspodent Contact joni creal
Regulation Number 870.3375
Classification Product Code
DTK  
Date Received 08/29/2011
Decision Date 10/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No