DORADO PTA BALLOON DILATATION CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K072283
Device Name DORADO PTA BALLOON DILATATION CATHETER
Applicant
BARD PERIPHERAL VASCULAR, INC.
1415 west 3rd st.
tempe, 
AZ 
85281

Applicant Contact genevieve balutowski
Regulation Number 870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received 08/16/2007
Decision Date 09/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls