VACCESS PTA BALLOON DILATATION CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K073472
Device Name VACCESS PTA BALLOON DILATATION CATHETER
Applicant
C.R. BARD, INC.
1625 west 3rd st.
tempe, 
AZ 
85281 -1740

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

Correspodent Contact jennifer logvin
Regulation Number 870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received 12/11/2007
Decision Date 01/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls