The Cardiva Catalyst™ II consists of a sterile disposable Catalyst II Wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst II System is intended to promote hemostasis at…
The Cardiva Catalyst™ II consists of a sterile disposable Catalyst II Wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Cardiva Catalyst II is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5F, 6F or 7F introducer sheaths.
Who Else Makes It
Concentrated in Beijing (3), Zhejiang (2), Guangdong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Cardiva Catalyst II VCS | Listed by | Cardiva Medical, Inc., Mexico |
| FDA product code | DXC |
| Device type | Clamp, Vascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4450 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2015-12-29 |
| Record revised | 2025-03-04 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 15 to 25 °C |
| Packaging | 10-pk carton of 10 |
| Sizes | Catheter gauge 5 to 7 Fr |
| Distribution end date | 2025-02-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.