FDA 510(k)

Catheter de Guía Equilibrado Sherpa NX 6F, Catheter de Guía Equilibrado Sherpa NX 7F

N.º K: K232190 · 2023-08-22

Fecha de decisión2023-08-22

Código de productoDQY

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide 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 2023-08-22 under 510(k) number K232190. 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 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter?

6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter is a medical device that received FDA 510(k) clearance on 2023-08-22. The listed applicant is Medtronic Vascular. The 510(k) number is K232190.

When did 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter receive FDA 510(k) clearance?

6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter received FDA 510(k) clearance on 2023-08-22, under 510(k) number K232190.

Who is the listed applicant for 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide 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 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter?

The FDA product code for 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter is DQY.

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Otros registros que enlistan a Medtronic Vascular como solicitante

K232570Steerant™ Super Stiff Guidewire 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)K192296Medtronic 6F Taiga Guiding Catheter K173515Admiral Xtreme K162097InTRAkit

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Fuente oficial

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