The following data is part of a premarket notification filed by Route 92 Medical with the FDA for Route 92 Medical 088 Access System.
| Device ID | K201518 |
| 510k Number | K201518 |
| Device Name: | Route 92 Medical 088 Access System |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Route 92 Medical 155 Bovet Road, Suite 100 San Mateo, CA 94402 |
| Contact | Kathy Tansey |
| Correspondent | Kathy Tansey Route 92 Medical 155 Bovet Road, Suite 100 San Mateo, CA 94402 |
| Product Code | QJP |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-08 |
| Decision Date | 2020-08-14 |