Device Classification Name |
catheter, retention type, balloon
|
510(k) Number |
K181616 |
Device Name |
PSM 3-Way Silicone Foley Catheter |
Applicant |
Pathway, LLC |
8779 Cottonwood Avenue, Suite 105 |
Santee,
CA
92071
|
|
Applicant Contact |
David Stroup |
Correspondent |
Pathway, LLC |
8779 Cottonwood Avenue, Suite 105 |
Santee,
CA
92071
|
|
Correspondent Contact |
David Stroup |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 06/19/2018 |
Decision Date | 09/21/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|