FDA 510(k)

Rebar Micro Catheter

K-Nummer: K210114 · 2021-02-16

AntragstellerMicro Therapeuatics, Inc. D/B/A Ev3 Neurovascular

Entscheidungsdatum2021-02-16

ProduktcodeKRA

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

Rebar Micro Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular. It received FDA 510(k) clearance on 2021-02-16 under 510(k) number K210114. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Rebar Micro Catheter?

Rebar Micro Catheter is a medical device that received FDA 510(k) clearance on 2021-02-16. The listed applicant is Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular. The 510(k) number is K210114.

When did Rebar Micro Catheter receive FDA 510(k) clearance?

Rebar Micro Catheter received FDA 510(k) clearance on 2021-02-16, under 510(k) number K210114.

Who is the listed applicant for Rebar Micro Catheter?

The FDA 510(k) record lists Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rebar Micro Catheter?

The FDA product code for Rebar Micro Catheter is KRA.

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Verwandte Geräte (Code: KRA)

K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences K254051Einführer InfusionskathetersystemSmartWise Sweden AB K261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation K250794InVera Infusion DeviceInvera Medical K243534Micro CatheterSuzhou Zenith Vascular SciTech Limited

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