OSPREY Closed IV Catheter System (OspreyV2)— 510(k) K231626

Substantially Equivalent

Skydance Vascular, Inc.

FDA 510(k) clearance K231626 for OSPREY Closed IV Catheter System (OspreyV2), Substantially Equivalent on 2023-08-31. Applicant: Skydance Vascular, Inc..

Clearance details

Applicant: Skydance Vascular, Inc.
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2023-06-02
Decision date: 2023-08-31
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.