The following data is part of a premarket notification filed by Transaortic Medical, Inc. with the FDA for Transglidext Expandable Introducer.
| Device ID | K181817 |
| 510k Number | K181817 |
| Device Name: | TransGlideXT Expandable Introducer |
| Classification | Introducer, Catheter |
| Applicant | TransAortic Medical, Inc. 135 E. Main Ave., Suite 170 Morgan Hill, CA 95037 |
| Contact | Richard Ginn |
| Correspondent | Diana Degregorio TransAortic Medical, Inc. 135 E. Main Ave., Suite 170 Morgan Hill, CA 95037 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-09 |
| Decision Date | 2019-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000233815 | K181817 | 000 |