ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED


Device Classification Name

prosthesis, tracheal, expandable

510(k) Number K121048
Device Name ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
Applicant
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough, 
MA 
01752

Applicant Contact janis f taranto
Correspondent
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough, 
MA 
01752

Correspodent Contact janis f taranto
Regulation Number 878.3720
Classification Product Code
JCT  
Date Received 04/06/2012
Decision Date 08/03/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No