Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K081394 |
Device Name |
PTFE INTERLOCK PEELABLE INTRODUCERS |
Applicant |
ENPATH MEDICAL, INC. |
2300 BERKSHIRE LANE NORTH |
MINNEAPOLIS,
MN
55441
|
|
Applicant Contact |
SHANNON SPRINGER |
Correspondent |
ENPATH MEDICAL, INC. |
2300 BERKSHIRE LANE NORTH |
MINNEAPOLIS,
MN
55441
|
|
Correspondent Contact |
SHANNON SPRINGER |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 05/19/2008 |
Decision Date | 09/15/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|