Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K152498 |
Device Name |
SoloPath Re-Collapsible Access System |
Applicant |
ONSET MEDICAL CORPORATION |
13900 ALTON PARKWAY, SUITE 120 |
IRVINE,
CA
92618
|
|
Applicant Contact |
Monika McDole-Russell |
Correspondent |
TERUMO Corporation |
265 Davidson Ave, Suite 320 |
Somerset,
NJ
08873
|
|
Correspondent Contact |
Monika McDole-Russell |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 09/01/2015 |
Decision Date | 01/05/2016 |
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
|
|
|