Nmt Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Nmt Medical, Inc. makes
Nmt Medical, Inc. manufactures transseptal sheath sets for cardiac procedures, including models designed for specific procedural needs such as TSS-10-HSC, TSS-11-HSC, and TSS-12-HSC. The company also produces Spetzler round handle appliers, such as models C-3753, C-3753T, C-3754, and C-3754T, which are used in surgical applications. Additionally, they supply the CardioSeal septal occlusion system with a QWIK LOAD mechanism, intended for closing atrial septal defects.
The company’s devices are regulated under both Class II and Class III classifications in the US, with some products authorised via the FDA’s 510(k) pathway and others through the Premarket Approval (PMA) process. These products are listed in the FDA’s regulatory databases for medical devices. Nmt Medical, Inc. is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Cardioseal Septal Occlusion System W/Qwik Load Ref K842102
Regimes: PMA 510(k) Registry: PMA
Frequently asked questions
How many devices does Nmt Medical, Inc. have in the registry?
The registry currently lists 3 devices for Nmt Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nmt Medical, Inc.'s devices?
Among its 3 most recently registered devices, Nmt Medical, Inc. has devices listed in FDA 510(k) (2 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Nmt Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Nmt Medical, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Nmt Medical, Inc. in the registry?
The most recently registered devices listed for Nmt Medical, Inc. include NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC, SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T and CARDIOSEAL SEPTAL OCCLUSION SYSTEM W/QWIK LOAD.