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 |