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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 the device name listed in this FDA 510(k) record. The listed applicant is Vygon USA. It received FDA 510(k) clearance on 2018-11-02 under 510(k) 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. The listed applicant is Vygon USA. The 510(k) number is K181208.

When did Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter receive FDA 510(k) clearance?

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 510(k) number K181208.

Who is the listed applicant for Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter?

The FDA 510(k) record lists Vygon USA as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Vygon USA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243361NutrifitK212370Leaderflex Mini and Leaderflex NanoK172899Vygon PICCs

Related Devices (Code: PND)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252402Midline CatheterTerumo Medical Products (Hangzhou) Co., Ltd.K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex IncorporatedK213203Provena(TM) Midline CatheterC.R. Bard, Inc.K210047Stiletto Extended Dwell CatheterPiper Access, LLCK192802primeMidline CathetersPfm Medical, Inc.K173114primeMidline CathetersPfm Medical, 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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