FDA 510(k)

Medtronic 6F Taiga Guiding Catheter

N.º K: K192296 · 2019-09-20

Fecha de decisión2019-09-20

Código de productoDQY

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medtronic 6F Taiga Guiding Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2019-09-20 under 510(k) number K192296. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Medtronic 6F Taiga Guiding Catheter?

Medtronic 6F Taiga Guiding Catheter is a medical device that received FDA 510(k) clearance on 2019-09-20. The listed applicant is Medtronic Vascular. The 510(k) number is K192296.

When did Medtronic 6F Taiga Guiding Catheter receive FDA 510(k) clearance?

Medtronic 6F Taiga Guiding Catheter received FDA 510(k) clearance on 2019-09-20, under 510(k) number K192296.

Who is the listed applicant for Medtronic 6F Taiga Guiding Catheter?

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 Medtronic 6F Taiga Guiding Catheter?

The FDA product code for Medtronic 6F Taiga Guiding Catheter is DQY.

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Otros registros que enlistan a Medtronic Vascular como solicitante

K232570Steerant™ Super Stiff Guidewire K232190Catheter de Guía Equilibrado Sherpa NX 6F, Catheter de Guía Equilibrado Sherpa NX 7F K230156Catheter guía de lanzamiento 5F, Catheter guía de lanzamiento 6F, Catheter guía de lanzamiento 7F, Catheter guía de lanzamiento 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)K173515Admiral Xtreme K162097InTRAkit

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Fuente oficial

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