Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K043489 |
Device Name |
ENPATH DEFLECTABLE CATHETER |
Applicant |
ENPATH MEDICAL INCORPORATED |
15301 HWY. 55 WEST |
MINNEAPOLIS,
MN
55447
|
|
Applicant Contact |
KARYL D HASKELL |
Correspondent |
ENPATH MEDICAL INCORPORATED |
15301 HWY. 55 WEST |
MINNEAPOLIS,
MN
55447
|
|
Correspondent Contact |
KARYL D HASKELL |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 12/17/2004 |
Decision Date | 05/19/2005 |
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
|
|
|