FDA 510(k)

Cathéter guide équilibré Sherpa NX 6F, Cathéter guide équilibré Sherpa NX 7F

Numéro K : K232190 · 2023-08-22

Date de décision2023-08-22

Code produitDQY

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Source officielle

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