The following data is part of a premarket notification filed by Pathway, Llc with the FDA for Hdx 100% Silicone 2-way Foley Catheter, 14fr/10cc, Hdx 100% Silicone 2-way Foley Catheter, 16fr/5cc, Hdx 100% Silicone 2-way Foley Catheter, 18fr/10cc.
| Device ID | K192034 |
| 510k Number | K192034 |
| Device Name: | HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | Pathway, LLC 8779 Cottonwood Avenue, Suite 105 Santee, CA 92071 |
| Contact | David Stroup |
| Correspondent | Aaron Rogers 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 | 2019-07-30 |
| Decision Date | 2020-04-21 |