WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM


Device Classification Name

prosthesis, tracheal, expandable

510(k) Number K021901
Device Name WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Original Applicant
BOSTON SCIENTIFIC SCIMED, INC.
one scimed place
maple grove, 
MN 
55311

Original Contact sherry l sparrow
Regulation Number 878.3720
Classification Product Code
JCT  
Date Received 06/10/2002
Decision Date 07/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls