The following data is part of a premarket notification filed by Route 92 Medical Inc. with the FDA for Route 92 Medical Full Length 088 Access System.
| Device ID | K210635 |
| 510k Number | K210635 |
| Device Name: | Route 92 Medical Full Length 088 Access System |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Route 92 Medical Inc. 155 Bovet Road, Suite 100 San Mateo, CA 94402 |
| Contact | Kirsten Valley |
| Correspondent | Kirsten Valley Route 92 Medical Inc. 155 Bovet Road, Suite 100 San Mateo, CA 94402 |
| Product Code | QJP |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-03 |
| Decision Date | 2021-07-27 |