The following data is part of a premarket notification filed by Pathway, Llc with the FDA for Psm 3-way Silicone Foley Catheter.
| Device ID | K181616 |
| 510k Number | K181616 |
| Device Name: | PSM 3-Way Silicone Foley Catheter |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | Pathway, LLC 8779 Cottonwood Avenue, Suite 105 Santee, CA 92071 |
| Contact | David Stroup |
| Correspondent | David Stroup Pathway, LLC 8779 Cottonwood Avenue, Suite 105 Santee, CA 92071 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-19 |
| Decision Date | 2018-09-21 |
| Summary: | summary |