Device Classification Name |
catheters, transluminal coronary angioplasty, percutaneous
|
510(k) Number |
K103110 |
FOIA Releasable 510(k) |
K103110
|
Device Name |
MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER |
Applicant |
ABBOTT VASCULAR-CARDIAC THERAPIES |
26531 YNEZ RD. |
MAILING P.O. BOX 9018 |
TEMECULA,
CA
92589 -9018
|
|
Applicant Contact |
SUZANNE REDMAN |
Correspondent |
ABBOTT VASCULAR-CARDIAC THERAPIES |
26531 YNEZ RD. |
MAILING P.O. BOX 9018 |
TEMECULA,
CA
92589 -9018
|
|
Correspondent Contact |
SUZANNE REDMAN |
Regulation Number | 870.5100
|
Classification Product Code |
|
Date Received | 10/08/2010 |
Decision Date | 01/10/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|