Datascope Corp., Cardiac Assist Division
United StatesFDA applicant, unverified
- Devices
- 4
What Datascope Corp., Cardiac Assist Division makes
Datascope Corp. manufactures intra-aortic balloon (IAB) catheters and associated accessories, including 50cc, 40cc, and 30cc balloon sizes with 7.5fr and 8fr catheters, as well as radial artery compression devices for vascular access.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Datascope's 8FR. 50cc Intra-Aortic Balloon Catheter And Accessories, Models 0684, 00-0498-01, 02 Ref K091449
Regimes: 510(k) Registry: 510(k)Air-Band Radial Compression Device Ref K122405
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 Datascope Corp., Cardiac Assist Division have in the registry?
The registry currently lists 4 devices for Datascope Corp., Cardiac Assist Division. Devices recorded under merged duplicate company entries are counted once.
Which registries list Datascope Corp., Cardiac Assist Division's devices?
Among its 4 most recently registered devices, Datascope Corp., Cardiac Assist Division has devices listed in FDA 510(k) (4 devices).
What risk classes do Datascope Corp., Cardiac Assist Division's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Datascope Corp., Cardiac Assist Division's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Datascope Corp., Cardiac Assist Division in the registry?
The most recently registered devices listed for Datascope Corp., Cardiac Assist Division include DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684, 00-0498-01, 02, AIR-BAND RADIAL COMPRESSION DEVICE, SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES and MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER.