MODIFICATION TO ENVOY AND VISTA BRITE TIP


Device Classification Name

catheter, percutaneous

510(k) Number K021593
Device Name MODIFICATION TO ENVOY AND VISTA BRITE TIP
Original Applicant
CORDIS CORP.
14201 n.w. 60th ave.
miami lakes, 
FL 
33014

Original Contact stephen m enos
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 05/15/2002
Decision Date 06/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No