Data / Medical devices / United States / Skydance Vascular, Inc.
Skydance Vascular, Inc.: FDA-registered device maker in Pleasant Grove, UT, United States, 3 510(k) clearances
Skydance Vascular, Inc. is registered with the FDA (registration 3022054170) in Pleasant Grove, UT, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated May 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022054170
- Address
- 3058 Millcreek Rd., Pleasant Grove, UT, United States, 84062
- Owner or operator
- SkyDance Vascular, Inc. (10087996)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 11, 2023
- Registered through
- 2026
- Brand names listed
- OSPREY Closed IV Catheter System (OspreyV2), OSPREY Midline Closed IV Catheter System (OspreyEDC), OSPREY PERIPHERAL IV Catheter System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 2, 2025 | K250292 | OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) | FOZ | Substantially Equivalent | Skydance Vascular, Inc. | accessdata.fda.gov |
| August 31, 2023 | K231626 | OSPREY Closed IV Catheter System (OspreyV2) | FOZ | Substantially Equivalent | Skydance Vascular, Inc. | accessdata.fda.gov |
| April 14, 2023 | K223018 | OSPREY PERIPHERAL IV Catheter System | FOZ | Substantially Equivalent | Skydance Vascular, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.