Cardiovascular Diagnostic Services
Country not established
- Devices
- 8
What Cardiovascular Diagnostic Services makes
Cardiovascular Diagnostic Services manufactures point-of-care coagulation testing devices and consumables, including APTT, PT, and PT-NC test cards for blood clotting analysis. Their portfolio also includes coagulation analyzers like the COAG-I Alpha Model and the TAS Analyzer, alongside accessories such as the Dorros-Spring Pressurizer and TAS Ptone for automated testing procedures.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company operates within the United States, adhering to US regulatory standards for diagnostic medical devices.
Catalogue
Coag-1 Aptt Test Card Ref K891015
Regimes: 510(k) Registry: 510(k)Coag-1 Pt-Nc Test Card Ref K904325
Regimes: 510(k) Registry: 510(k)Modified Coag-1 Pt Test Card Ref K903019
Regimes: 510(k) Registry: 510(k)Coag-I Analyzer, Alpha Model Ref K882444
Regimes: 510(k) Registry: 510(k)Tas Analyzer Ref K933092
Regimes: 510(k) Registry: 510(k)Dorros-Spring Pressurizer Ref K812304
Regimes: 510(k) Registry: 510(k)Tas Ptone Ref K955843
Regimes: 510(k) Registry: 510(k)Coag-I Pt Test Card Ref K882456
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardiovascular Diagnostic Services have in the registry?
The registry currently lists 8 devices for Cardiovascular Diagnostic Services. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiovascular Diagnostic Services's devices?
Among its 8 most recently registered devices, Cardiovascular Diagnostic Services has devices listed in FDA 510(k) (8 devices).
What risk classes do Cardiovascular Diagnostic Services's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Cardiovascular Diagnostic Services's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardiovascular Diagnostic Services in the registry?
The most recently registered devices listed for Cardiovascular Diagnostic Services include COAG-1 APTT TEST CARD, COAG-1 PT-NC TEST CARD, MODIFIED COAG-1 PT TEST CARD and COAG-I ANALYZER, ALPHA MODEL.