OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)— 510(k) K250292

Substantially Equivalent

Skydance Vascular, Inc.

FDA 510(k) clearance K250292 for OSPREY Midline Closed IV Catheter System (OspreyEDC-F20), Substantially Equivalent on 2025-05-02. Applicant: Skydance Vascular, Inc..

Clearance details

Applicant: Skydance Vascular, Inc.
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2025-01-31
Decision date: 2025-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasant Grove, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.