Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K140536 |
Device Name |
HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE |
Applicant |
LAKE REGION MEDICAL |
LAKE REGION MED INTL R&D CTR |
PARKMORE WEST BUSINESS |
GALWAY,
IE
IRELAND
|
|
Applicant Contact |
KENNETH WALSH |
Correspondent |
LAKE REGION MEDICAL |
LAKE REGION MED INTL R&D CTR |
PARKMORE WEST BUSINESS |
GALWAY,
IE
IRELAND
|
|
Correspondent Contact |
KENNETH WALSH |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 03/04/2014 |
Decision Date | 12/17/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|