The following data is part of a premarket notification filed by Galt Medical Corp. with the FDA for Sterile Dilator.
| Device ID | K192195 |
| 510k Number | K192195 |
| Device Name: | Sterile Dilator |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | Galt Medical Corp. 2220 Merritt Dr. Garland, TX 75041 |
| Contact | David Derrick |
| Correspondent | David Derrick Galt Medical Corp. 2220 Merritt Dr. Garland, TX 75041 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-13 |
| Decision Date | 2019-09-26 |
| Summary: | summary |