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FDA 510(k)

OSPREY PERIPHERAL IV Catheter System

K-Number: K223018 · 2023-04-14

ApplicantSkydance Vascular, Inc.
Decision Date2023-04-14
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OSPREY PERIPHERAL IV Catheter System is a medical device manufactured by Skydance Vascular, Inc.. It received FDA 510(k) clearance on 2023-04-14 under approval number K223018. 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 PERIPHERAL IV Catheter System?

OSPREY PERIPHERAL IV Catheter System is a medical device that received FDA 510(k) clearance on 2023-04-14. It is manufactured by Skydance Vascular, Inc.. The 510(k) number is K223018.

When was OSPREY PERIPHERAL IV Catheter System approved by the FDA?

OSPREY PERIPHERAL IV Catheter System received FDA 510(k) clearance on 2023-04-14, under approval number K223018.

What company makes OSPREY PERIPHERAL IV Catheter System?

OSPREY PERIPHERAL IV Catheter System is manufactured by Skydance Vascular, Inc..

What is the FDA product code for OSPREY PERIPHERAL IV Catheter System?

The FDA product code for OSPREY PERIPHERAL IV Catheter System is FOZ.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT04246281 The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain COMPLETED NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING

Related PubMed Literature

PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025)

Other Devices by Skydance Vascular, Inc.

K231626OSPREY Closed IV Catheter System (OspreyV2) K250292OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)

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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