Device Classification Name |
Tube Tracheostomy And Tube Cuff
|
510(k) Number |
K142296 |
Device Name |
Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula |
Applicant |
Covidien |
6135 Gunbarrel Ave |
Boulder,
CO
80301
|
|
Applicant Contact |
Danielle Mueller |
Correspondent |
Covidien |
6135 Gunbarrel Ave |
Boulder,
CO
80301
|
|
Correspondent Contact |
Danielle Mueller |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 08/18/2014 |
Decision Date | 02/24/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|