Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K182457 |
Device Name |
Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J |
Applicant |
Brivant Limited (Lake Region Medical) |
Parkmore West Business Park |
Galway,
IE
H91 CK22
|
|
Applicant Contact |
Tom J. Healy |
Correspondent |
Brivant Limited (Lake Region Medical) |
Parkmore West Business Park |
Galway,
IE
H91 CK22
|
|
Correspondent Contact |
Tom J. Healy |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 09/07/2018 |
Decision Date | 04/18/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|