Class Class II

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

K250292 2025-05-02 Traditional
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Description

OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) by Skydance Vascular, Inc., an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250292
Clearance Date2025-05-02
Clearance TypeTraditional
Product CodeFOZ
Regulation Number880.5200

Categories

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Predicate lineage for K250292

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) (K250292) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K231626OSPREY Closed IV Catheter System (OspreyV2)Skydance Vascular, Inc.2023

Trace the full predicate network for K250292

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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