FDA 510(k)

Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Cateter

Número K: K261825 · 2026-07-02

RequerenteAbbott

Data da decisão2026-07-02

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Abbott. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K261825. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter?

Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Abbott. The 510(k) number is K261825.

When did Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter receive FDA 510(k) clearance?

Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter received FDA 510(k) clearance on 2026-07-02, under 510(k) number K261825.

Who is the listed applicant for Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter?

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

What is the FDA product code for Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter?

The FDA product code for Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter is DQY.

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Outros registros que listam Abbott como candidato(a)

K260993Amplatzer TorqVue Delivery System K251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)K233655Lingo Glucose System K222297CentriMag Pre-connected Pack K221213EnSite X EP System K212061EnSite X EP System

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Dispositivos Relacionados (Código: DQY)

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLC K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC K261631Amplatzer TorqVue Exchange SystemAbbott Medical

Fonte oficial

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