The following data is part of a premarket notification filed by Galt Medical Corp. with the FDA for Coaxial Dilator Set (micro-introducer).
| Device ID | K172487 |
| 510k Number | K172487 |
| Device Name: | Coaxial Dilator Set (Micro-Introducer) |
| 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 - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-17 |
| Decision Date | 2017-10-16 |
| Summary: | summary |