The following data is part of a premarket notification filed by Galt Medical Corp. with the FDA for Tearaway Introducer Sheath, Microslide Tearaway Introducer.
| Device ID | K153533 |
| 510k Number | K153533 |
| Device Name: | Tearaway Introducer Sheath, MicroSlide 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 | 2015-12-09 |
| Decision Date | 2016-07-05 |
| Summary: | summary |