The following data is part of a premarket notification filed by Route 92 Medical Inc. with the FDA for Route 92 Medical Sheath System.
| Device ID | K191717 |
| 510k Number | K191717 |
| Device Name: | Route 92 Medical Sheath System |
| Classification | Catheter, Percutaneous |
| Applicant | Route 92 Medical Inc. 1700 S. El Camino Real, Suite 206 San Mateo, CA 94402 |
| Contact | Kathy Tansey |
| Correspondent | Kathy Tansey Route 92 Medical Inc. 1700 S. El 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 | 2019-06-26 |
| Decision Date | 2020-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853799007404 | K191717 | 000 |