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FDA 510(k)

OSPREY Closed IV Catheter System (OspreyV2)

K-Number: K231626 · 2023-08-31

ApplicantSkydance Vascular, Inc.
Decision Date2023-08-31
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OSPREY Closed IV Catheter System (OspreyV2) is a medical device manufactured by Skydance Vascular, Inc.. It received FDA 510(k) clearance on 2023-08-31 under approval number K231626. 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 Closed IV Catheter System (OspreyV2)?

OSPREY Closed IV Catheter System (OspreyV2) is a medical device that received FDA 510(k) clearance on 2023-08-31. It is manufactured by Skydance Vascular, Inc.. The 510(k) number is K231626.

When was OSPREY Closed IV Catheter System (OspreyV2) approved by the FDA?

OSPREY Closed IV Catheter System (OspreyV2) received FDA 510(k) clearance on 2023-08-31, under approval number K231626.

What company makes OSPREY Closed IV Catheter System (OspreyV2)?

OSPREY Closed IV Catheter System (OspreyV2) is manufactured by Skydance Vascular, Inc..

What is the FDA product code for OSPREY Closed IV Catheter System (OspreyV2)?

The FDA product code for OSPREY Closed IV Catheter System (OspreyV2) is FOZ.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_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 NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING

Other Devices by Skydance Vascular, Inc.

K223018OSPREY PERIPHERAL IV Catheter System 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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