The following data is part of a premarket notification filed by Route 92 Medical, Inc. with the FDA for Route 92 Medical Access System.
| Device ID | K180201 |
| 510k Number | K180201 |
| Device Name: | Route 92 Medical Access System |
| Classification | Catheter, Percutaneous |
| Applicant | Route 92 Medical, Inc. 1700 S EI Camino Real Suite 206 San Mateo, CA 94402 |
| Contact | Kirsten Valley |
| Correspondent | Kirsten Valley Route 92 Medical, Inc. 1700 S EI Camino Real Suite 206 San Mateo, CA 94402 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-24 |
| Decision Date | 2018-05-23 |
| Summary: | summary |