Device Classification Name |
Catheter, Angioplasty, Peripheral, Transluminal
More FDA Info for this Device |
510(K) Number |
K143093 |
Device Name |
Catheter, Angioplasty, Peripheral, Transluminal |
Applicant |
HOTSPUR TECHNOLOGIES, INC.,
880 MAUDE AVENUE, SUITE A
MOUNTAIN VIEW, CA 94043 US
Other 510(k) Applications for this Company
|
Contact |
Eric Ankerud, JD
Other 510(k) Applications for this Contact |
Regulation Number |
870.1250
More FDA Info for this Regulation Number |
Classification Product Code |
LIT
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
10/28/2014 |
Decision Date |
06/24/2015 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CV - Cardiovascular |
Review Advisory Committee |
CV - Cardiovascular |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|