The following data is part of a premarket notification filed by Transaortic Medical, Inc. with the FDA for Transglide Expandable Introducer.
| Device ID | K152194 |
| 510k Number | K152194 |
| Device Name: | TransGlide 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 | 2015-08-05 |
| Decision Date | 2016-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866697000224 | K152194 | 000 |
| 00866697000217 | K152194 | 000 |
| 00866697000200 | K152194 | 000 |