The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Destino Reach.
| Device ID | K151951 |
| 510k Number | K151951 |
| Device Name: | Destino Reach |
| Classification | Introducer, Catheter |
| Applicant | Oscor Inc. 3816 DeSoto Blvd Palm Harbor, FL 34683 |
| Contact | Jan Flegeau |
| Correspondent | Jan Flegeau Oscor Inc. 3816 DeSoto Blvd Palm Harbor, FL 34683 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-15 |
| Decision Date | 2015-09-22 |
| Summary: | summary |