Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K091367 |
Device Name |
GDS-DCS |
Applicant |
GUIDED DELIVERY SYSTEMS |
2355 CALLE DE LUNA |
SANTA CLARA,
CA
95054
|
|
Applicant Contact |
BONNIE MCINERNEY |
Correspondent |
GUIDED DELIVERY SYSTEMS |
2355 CALLE DE LUNA |
SANTA CLARA,
CA
95054
|
|
Correspondent Contact |
BONNIE MCINERNEY |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 05/08/2009 |
Decision Date | 11/05/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|