Device Classification Name |
Dilator, Catheter, Ureteral
|
510(k) Number |
K043254 |
Device Name |
PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH |
Applicant |
ONSET MEDICAL CORPORATION |
27001 LA PAZ SUITE 312 |
MISSION VIEJO,
CA
92691
|
|
Applicant Contact |
ALBERT REGO |
Correspondent |
ONSET MEDICAL CORPORATION |
27001 LA PAZ SUITE 312 |
MISSION VIEJO,
CA
92691
|
|
Correspondent Contact |
ALBERT REGO |
Regulation Number | 876.5470
|
Classification Product Code |
|
Date Received | 11/24/2004 |
Decision Date | 02/10/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|