Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K122573 |
Device Name |
HI-TORQUE COMMAND GUIDE WIRE FAMILY |
Applicant |
ABBOTT VASCULAR INC. |
26531 YNEZ ROAD, BUILDING G |
MALING P.O. 9018 |
TEMECULA,
CA
92590 -9018
|
|
Applicant Contact |
KAY SETZER |
Correspondent |
ABBOTT VASCULAR INC. |
26531 YNEZ ROAD, BUILDING G |
MALING P.O. 9018 |
TEMECULA,
CA
92590 -9018
|
|
Correspondent Contact |
KAY SETZER |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 08/23/2012 |
Decision Date | 11/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|