Smec, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Smec, Inc. makes
Smec, Inc. manufactures intra-aortic balloon systems, including percutaneous and modified versions designed for temporary circulatory support. These devices are used in cardiac procedures to augment blood flow and reduce myocardial oxygen demand. The portfolio includes balloon cannulas and pressure-triggered modifications for intra-aortic applications.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The products are listed in the FDA’s 510(k) database. Smec, Inc. is headquartered in the United States.
Catalogue
Intra-Aortic Balloon System Ref K823739
Regimes: 510(k) Registry: 510(k)Smec Balloon System Ref K823177
Regimes: 510(k) Registry: 510(k)Modified Smec Percutaneous Intra-Aortic Ref K840037
Regimes: 510(k) Registry: 510(k)Modification Of The Percutan-Balloon Ref K813355
Regimes: 510(k) Registry: 510(k)Pressure Trigger Mod Of Smec Intra-Aort Ref K840367
Regimes: 510(k) Registry: 510(k)Percutaneous Balloon Ref K832753
Regimes: 510(k) Registry: 510(k)Smec Balloon Cannula Ref K790755
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Smec, Inc. have in the registry?
The registry currently lists 7 devices for Smec, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smec, Inc.'s devices?
Among its 7 most recently registered devices, Smec, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Smec, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Smec, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Smec, Inc. in the registry?
The most recently registered devices listed for Smec, Inc. include INTRA-AORTIC BALLOON SYSTEM, SMEC BALLOON SYSTEM, MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC and MODIFICATION OF THE PERCUTAN-BALLOON.