Xablecath, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Xablecath, Inc. makes
Xablecath, Inc. manufactures catheters designed for vascular access and intervention, including the XableCath Crossing Catheter for navigating complex vessel pathways and the XableCath Support Catheter Product Family for procedural support.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
XableCath Crossing Catheter Ref K183357
Regimes: 510(k) Registry: 510(k)XableCath Support Catheter Product Family Ref K180986
Regimes: 510(k) Registry: 510(k)XableCath Support Catheter Ref K170041
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Xablecath, Inc. have in the registry?
The registry currently lists 3 devices for Xablecath, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xablecath, Inc.'s devices?
Among its 3 most recently registered devices, Xablecath, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Xablecath, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Xablecath, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Xablecath, Inc. in the registry?
The most recently registered devices listed for Xablecath, Inc. include XableCath Crossing Catheter, XableCath Support Catheter Product Family and XableCath Support Catheter.