The following data is part of a premarket notification filed by Galt Medical Corp. with the FDA for Galttws.
| Device ID | K182660 |
| 510k Number | K182660 |
| Device Name: | GaltTWS |
| Classification | Stylet, 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 | DRB |
| Subsequent Product Code | DQX |
| Subsequent Product Code | DTL |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-25 |
| Decision Date | 2019-05-30 |