CONVOY ADVANCED DELIVERY SHEATH


Device Classification Name

fab, rhodamine, antigen, antiserum, control

510(k) Number K022067
Device Name CONVOY ADVANCED DELIVERY SHEATH
Original Applicant
BOSTON SCIENTIFIC
2710 orchard pkwy.
san jose, 
CA 
95134

Original Contact andrea l ruth
Regulation Number 866.5520
Classification Product Code
DBY  
Date Received 06/25/2002
Decision Date 09/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls