Device Classification Name |
introducer, catheter
|
510(k) Number |
K123990 |
Device Name |
SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING |
Applicant |
MEDTRONIC VASCULAR |
3576 Unocal Place |
Santa Rosa,
CA
95403
|
|
Applicant Contact |
KELLEY LAMKE |
Correspondent |
MEDTRONIC VASCULAR |
3576 Unocal Place |
Santa Rosa,
CA
95403
|
|
Correspondent Contact |
KELLEY LAMKE |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 12/26/2012 |
Decision Date | 04/26/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|