FDA 510(k)

Steerant™ Super Stiff Guidewire

Número K: K232570 · 2023-10-24

Data da decisão2023-10-24

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Steerant™ Super Stiff Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K232570. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Steerant™ Super Stiff Guidewire?

Steerant™ Super Stiff Guidewire is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is Medtronic Vascular. The 510(k) number is K232570.

When did Steerant™ Super Stiff Guidewire receive FDA 510(k) clearance?

Steerant™ Super Stiff Guidewire received FDA 510(k) clearance on 2023-10-24, under 510(k) number K232570.

Who is the listed applicant for Steerant™ Super Stiff Guidewire?

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

What is the FDA product code for Steerant™ Super Stiff Guidewire?

The FDA product code for Steerant™ Super Stiff Guidewire is DQX.

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Outros registros que listam Medtronic Vascular como candidato(a)

K232190Catheter de Guia Balanceado Sherpa NX 6F, Catheter de Guia Balanceado Sherpa NX 7F K230156Catheter Guia de Lançamento 5F, Catheter Guia de Lançamento 6F, Catheter Guia de Lançamento 7F, Catheter Guia de Lançamento 8F K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)K192296Medtronic 6F Taiga Guiding Catheter K173515Admiral Xtreme K162097InTRAkit

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Fonte oficial

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