Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K132030 |
Device Name |
MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING |
Applicant |
MEDTRONIC INC. |
8200 CORAL SEA STREET |
MS MVS11 |
MOUNDS VIEW,
MN
55112
|
|
Applicant Contact |
CHECHAMMA VARUGHESE |
Correspondent |
MEDTRONIC INC. |
8200 CORAL SEA STREET |
MS MVS11 |
MOUNDS VIEW,
MN
55112
|
|
Correspondent Contact |
CHECHAMMA VARUGHESE |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 07/01/2013 |
Decision Date | 09/27/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|