The following data is part of a premarket notification filed by Galt Medical Corp. with the FDA for Galt Vti Low Insertion Valve Tearaway Introducer.
| Device ID | K140028 |
| 510k Number | K140028 |
| Device Name: | GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-06 |
| Decision Date | 2014-08-21 |
| Summary: | summary |