Skydance Vascular, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3022054170
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
What Skydance Vascular, Inc. makes
SKYDANCE VASCULAR, INC. manufactures closed-system intravenous (IV) catheters designed for peripheral, midline, and central venous access. Their products include the OSPREY Closed IV Catheter System, the OSPREY PERIPHERAL IV Catheter System, and the OSPREY Midline Closed IV Catheter System (OspreyEDC-F20), which are intended to reduce contamination risks during fluid administration.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company’s products are intended for use in the United States, where they are subject to compliance with U.S. medical device regulations.
Catalogue
OSPREY Closed IV Catheter System (OspreyV2) Ref K231626
Regimes: 510(k) Registry: 510(k)OSPREY PERIPHERAL IV Catheter System Ref K223018
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3022054170
- Address
- 3058 Millcreek Rd., Pleasant Grove, UT, 84062
Frequently asked questions
How many devices does SKYDANCE VASCULAR, INC. have in the registry?
The registry currently lists 3 devices for SKYDANCE VASCULAR, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list SKYDANCE VASCULAR, INC.'s devices?
Among its 3 most recently registered devices, SKYDANCE VASCULAR, INC. has devices listed in FDA 510(k) (3 devices).
What risk classes do SKYDANCE VASCULAR, INC.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for SKYDANCE VASCULAR, INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from SKYDANCE VASCULAR, INC. in the registry?
The most recently registered devices listed for SKYDANCE VASCULAR, INC. include OSPREY Closed IV Catheter System (OspreyV2), OSPREY PERIPHERAL IV Catheter System and OSPREY Midline Closed IV Catheter System (OspreyEDC-F20).