Contract manufacturerPATHWAY MEDTECH, LLC. (Santee, CA)CaliforniaCardiovascularGastroenterology and urologyGeneral hospitalNeurologyPathologyClass IIClass I
PATHWAY MEDTECH, LLC.
Contract manufacturer · Santee, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3012833053 (openFDA record; or search FDA's registration database)
- FEI number
- 3012833053
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- Pathway Medtech, LLC. (FDA owner/operator no. 10052260)
- Registered address
- 8779 Cottonwood Ave Ste 105, Santee, CA 92071
- Contract listings
- 8 device listings, 7 product codes, first listed Nov 3, 2020
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DXF | Catheter, Septostomy | Class II | Cardiovascular | Contract manufacturing | Feb 19, 2025 |
| EZL | Catheter, Retention Type, Balloon | Class II | Gastroenterology and urology | Contract manufacturing | Nov 3, 2020 |
| FHN | Ligator, Hemorrhoidal | Class II | Gastroenterology and urology | Contract manufacturing | Nov 17, 2020 |
| FMF | Syringe, Piston | Class II | General hospital | Contract manufacturing | Nov 10, 2023 |
| HAO | Instrument, Surgical, Non-Powered | Class I | Neurology | Contract manufacturing | Nov 21, 2024 |
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | Class I | Pathology | Contract manufacturing | Oct 18, 2022 |
| OBJ | Catheter, Ultrasound, Intravascular | Class II | Cardiovascular | Contract manufacturing | Dec 3, 2025 |