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FDA 510(k)

Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter

K-Number: K181208 · 2018-11-02

ApplicantVygon USA
Decision Date2018-11-02
Product CodePND
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter is a medical device manufactured by Vygon USA. It received FDA 510(k) clearance on 2018-11-02 under approval number K181208. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter?

Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter is a medical device that received FDA 510(k) clearance on 2018-11-02. It is manufactured by Vygon USA. The 510(k) number is K181208.

When was Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter approved by the FDA?

Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter received FDA 510(k) clearance on 2018-11-02, under approval number K181208.

What company makes Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter?

Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter is manufactured by Vygon USA.

What is the FDA product code for Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter?

The FDA product code for Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter is PND.

Related Clinical Trials

NCT07610681 Midline Catheter Study ACTIVE_NOT_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 NCT06979167 Complications of Midline Catheter in Surgical Children COMPLETED NCT06770374 Effectiveness of a Zinc Oxide Adhesive Securement Device in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients RECRUITING NCT06884176 CVCs Versus Midline Catheters NOT_YET_RECRUITING

Other Devices by Vygon USA

K172899Vygon PICCs K212370Leaderflex Mini and Leaderflex Nano K243361Nutrifit

Related Devices (Code: PND)

K162900PowerMidline CatheterC.R. Bard, Inc. K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic TechnologyArrow International, Inc. (Subsidiary of Teleflex, Inc.) K153393PowerMidline CatheterC.R. Bard, Inc. K171483ArchFlo CT MidlineMedcomp (Dba Medical Components, Inc.) K170770CT MidlineMedical Components, Inc. (dba MedComp) K170158PowerGlide ST Midline CatheterC.R. Bard, Inc.

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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