Device Classification Name |
introducer, catheter
|
510(k) Number |
K160254 |
Device Name |
GORE DrySeal Flex Introducer Sheath |
Applicant |
W.L. GORE & ASSOCIATES, INC. |
1505 N FOURTH STREET |
Flagstaff,
AZ
86004
|
|
Applicant Contact |
Mary Townsend |
Correspondent |
W.L. GORE & ASSOCIATES, INC. |
1505 N FOURTH STREET |
Flagstaff,
AZ
86004
|
|
Correspondent Contact |
Mary Townsend |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 02/01/2016 |
Decision Date | 05/12/2016 |
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
|
|
|