The following data is part of a premarket notification filed by Galt Medical Corp. with the FDA for Elite Hv Radial.
| Device ID | K173287 |
| 510k Number | K173287 |
| Device Name: | Elite HV Radial |
| Classification | Introducer, Catheter |
| Applicant | Galt Medical Corp. 2220 Merritt Drive Garland, TX 75087 |
| Contact | David Derrick |
| Correspondent | David Derrick Galt Medical Corp. 2220 Merritt Drive Garland, TX 75087 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-16 |
| Decision Date | 2017-12-21 |
| Summary: | summary |