Device Classification Name |
introducer, catheter
|
510(k) Number |
K121404 |
Device Name |
SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM |
Applicant |
ONSET MEDICAL CORPORATION |
13900 ALTON PARKWAY, SUITE 120 |
IRVINE,
CA
92618
|
|
Applicant Contact |
JOSEPH BISHOP |
Correspondent |
ONSET MEDICAL CORPORATION |
13900 ALTON PARKWAY, SUITE 120 |
IRVINE,
CA
92618
|
|
Correspondent Contact |
JOSEPH BISHOP |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 05/10/2012 |
Decision Date | 05/03/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|