Device Classification Name |
mechanical thrombolysis catheter
|
510(k) Number |
K130904 |
Device Name |
TRELLIS-8 PERIPHERAL INFUSION SYSTEM |
Applicant |
COVIDIEN |
15 HAMPSHIRE STREET |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
JENNIFER SULLIVAN |
Correspondent |
COVIDIEN |
15 HAMPSHIRE STREET |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
JENNIFER SULLIVAN |
Regulation Number | 870.5150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/01/2013 |
Decision Date | 10/25/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|