Transaortic Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Transaortic Medical, Inc. makes
Transaortic Medical, Inc. manufactures expandable introducer catheters designed for vascular access procedures, including the transGlide and transGlideXT series. These devices are intended for guiding and dilating vessels during interventions, such as peripheral and transradial catheterizations.
The company’s products are regulated as Class II medical devices in the US and are listed under FDA’s 510(k) and UDI programs. The portfolio is authorised for commercial distribution in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
transGlideXT Expandable Introducer Ref K181817
Regimes: 510(k) Registry: 510(k)transGlide Expandable Introducer Ref K152194
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Transaortic Medical, Inc. have in the registry?
The registry currently lists 5 devices for Transaortic Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Transaortic Medical, Inc.'s devices?
Among its 5 most recently registered devices, Transaortic Medical, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Transaortic Medical, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Transaortic Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Transaortic Medical, Inc. in the registry?
The most recently registered devices listed for Transaortic Medical, Inc. include transGlide Expandable Introducer 16F transGlide Expandable Introducer, transGlide Expandable Introducer 20F transGlide Expandable Introducer, transGlide Expandable Introducer 18F transGlide Expandable Introducer and transGlideXT Expandable Introducer.