AGILTRAC .035 PERIPHERAL DILATATION CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K022738
Device Name AGILTRAC .035 PERIPHERAL DILATATION CATHETER
Original Applicant
GUIDANT CORP.
1525 o’brien dr.
menlo park, 
CA 
94025

Original Contact nadine sakakini
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 08/19/2002
Decision Date 09/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No