Device Classification Name |
introducer, catheter
|
510(k) Number |
K173287 |
Device Name |
Elite HV Radial |
Applicant |
Galt Medical Corp. |
2220 Merritt Drive |
Garland,
TX
75087
|
|
Applicant Contact |
David Derrick |
Correspondent |
Galt Medical Corp. |
2220 Merritt Drive |
Garland,
TX
75087
|
|
Correspondent Contact |
David Derrick |
Regulation Number | 870.1340
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/16/2017 |
Decision Date | 12/21/2017 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|