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FDA 510(k)

OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)

K-Number: K250292 · 2025-05-02

ApplicantSkydance Vascular, Inc.
Decision Date2025-05-02
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) is a medical device manufactured by Skydance Vascular, Inc.. It received FDA 510(k) clearance on 2025-05-02 under approval number K250292. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)?

OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) is a medical device that received FDA 510(k) clearance on 2025-05-02. It is manufactured by Skydance Vascular, Inc.. The 510(k) number is K250292.

When was OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) approved by the FDA?

OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) received FDA 510(k) clearance on 2025-05-02, under approval number K250292.

What company makes OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)?

OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) is manufactured by Skydance Vascular, Inc..

What is the FDA product code for OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)?

The FDA product code for OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) is FOZ.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING

Other Devices by Skydance Vascular, Inc.

K231626OSPREY Closed IV Catheter System (OspreyV2) K223018OSPREY PERIPHERAL IV Catheter System

Related Devices (Code: FOZ)

K162894AccuCath Intravascular CatheterC.R. Bard, Inc. K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterMedsource International, LLC K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc. K161866BioFlo Midline CatheterNavilyst Medical, Inc. K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. K160592SUPERCATH 6Togo Medikit Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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