Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K063182 |
Device Name |
ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX |
Applicant |
ENPATH MEDICAL, INC. |
15301 HWY. 55 WEST |
MINNEAPOLIS,
MN
55447
|
|
Applicant Contact |
JAMES JENKINS |
Correspondent |
ENPATH MEDICAL, INC. |
15301 HWY. 55 WEST |
MINNEAPOLIS,
MN
55447
|
|
Correspondent Contact |
JAMES JENKINS |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 10/19/2006 |
Decision Date | 12/21/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|