Spectrum Medical S.r.l.
ItalyFDA applicant, unverified
- Devices
- 6
What Spectrum Medical S.r.l. makes
Spectrum Medical S.R.L. manufactures extracorporeal circulation devices, including hybrid perfusion systems, dual-lumen cannulas, centrifugal blood pumps with integrated sensors, and heat exchangers for cardiac and perfusion applications. Their portfolio also includes blood oxygenators designed for use in extracorporeal circuit systems, such as those used in cardiopulmonary bypass procedures.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. Their products are based in the United States.
Catalogue
Quantum Perfusion Hybrid System Ref K241206
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spectrum Medical S.R.L. have in the registry?
The registry currently lists 6 devices for Spectrum Medical S.R.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spectrum Medical S.R.L.'s devices?
Among its 6 most recently registered devices, Spectrum Medical S.R.L. has devices listed in FDA 510(k) (6 devices).
What risk classes do Spectrum Medical S.R.L.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Spectrum Medical S.R.L.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spectrum Medical S.R.L. in the registry?
The most recently registered devices listed for Spectrum Medical S.R.L. include Quantum Perfusion Hybrid System, Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1), Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) and Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W.