Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K080364 |
Device Name |
FINDRWIRZ GUIDE WIRE SYSTEM |
Applicant |
SENTREHEART INC. |
2468 EMBARCADERO WAY |
PALO ALTO,
CA
94303
|
|
Applicant Contact |
LINDA GUTHRIE |
Correspondent |
SENTREHEART INC. |
2468 EMBARCADERO WAY |
PALO ALTO,
CA
94303
|
|
Correspondent Contact |
LINDA GUTHRIE |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 02/11/2008 |
Decision Date | 08/11/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|