Device Classification Name |
introducer, catheter
|
510(k) Number |
K100819 |
Device Name |
THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER |
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 | 03/23/2010 |
Decision Date | 08/02/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|