Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K131079 |
Device Name |
CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC |
Applicant |
CREGANNA MEDICAL DEVICES |
386 WEST MAIN STREET SUITE 7 |
NORTHBOROUGH,
MA
01532
|
|
Applicant Contact |
CHRISTINE NICHOLS |
Correspondent |
CREGANNA MEDICAL DEVICES |
386 WEST MAIN STREET SUITE 7 |
NORTHBOROUGH,
MA
01532
|
|
Correspondent Contact |
CHRISTINE NICHOLS |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 04/17/2013 |
Decision Date | 08/01/2013 |
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
|
|
|