FDA 510(k)

Wattson Temporary Pacing Guidewire

Numéro K : K192454 · 2020-01-15

Date de décision2020-01-15

Code produitDQX

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Wattson Temporary Pacing Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions. It received FDA 510(k) clearance on 2020-01-15 under 510(k) number K192454. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Wattson Temporary Pacing Guidewire?

Wattson Temporary Pacing Guidewire is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Vascular Solutions. The 510(k) number is K192454.

When did Wattson Temporary Pacing Guidewire receive FDA 510(k) clearance?

Wattson Temporary Pacing Guidewire received FDA 510(k) clearance on 2020-01-15, under 510(k) number K192454.

Who is the listed applicant for Wattson Temporary Pacing Guidewire?

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

What is the FDA product code for Wattson Temporary Pacing Guidewire?

The FDA product code for Wattson Temporary Pacing Guidewire is DQX.

Essais cliniques associés

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Dispositifs connexes (Code : DQX)

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Source officielle

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