Cardio Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Cardio Systems, Inc. makes
Cardio Systems, Inc. manufactures medical devices for critical care and surgical applications, including autotransfusion systems for rapid blood recovery, low air loss mattress modifications for patient support, and add-ons for critical patient care beds. The company also produces oxygenator gas line filters, modifications to orbital atherectomy systems, cardioplegia solution administration sets, and orbital pad systems for vascular procedures. Additional offerings include a valve system designed for blood flow control and specialized equipment for cardiac perfusion.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with most products subject to 510(k) clearance. These devices are listed in the FDA’s 510(k) registry, reflecting their regulatory status in the United States. The manufacturer operates from the US.
Catalogue
Baylor Rapid Autotransfusion System Ref K852736
Regimes: 510(k) Registry: 510(k)Low Air Loss Mattress, Modification Ref K934689
Regimes: 510(k) Registry: 510(k)Add-On To Critical Patient Care Bed Ref K882177
Regimes: 510(k) Registry: 510(k)Zak-2000 Ref K972022
Regimes: 510(k) Registry: 510(k)Oxygenator Gas Line Filter Ref K792151
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Cardioplegia Solution Admin. Set Ref K792152
Regimes: 510(k) Registry: 510(k)Stealth 360 Orbital Pad System Ref K131092
Regimes: 510(k) Registry: 510(k)Centri-Safe(Tm) Valve Ref K921500
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardio Systems, Inc. have in the registry?
The registry currently lists 9 devices for Cardio Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardio Systems, Inc.'s devices?
Among its 9 most recently registered devices, Cardio Systems, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Cardio Systems, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Cardio Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardio Systems, Inc. in the registry?
The most recently registered devices listed for Cardio Systems, Inc. include BAYLOR RAPID AUTOTRANSFUSION SYSTEM, LOW AIR LOSS MATTRESS, MODIFICATION, ADD-ON TO CRITICAL PATIENT CARE BED and ZAK-2000.