FDA 510(k)

ensemble de manchon et dilatateur 10F

Numéro K : K233432 · 2023-12-08

Date de décision2023-12-08

Code produitDYB

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

10F Sheath and Dilator Set is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2023-12-08 under 510(k) number K233432. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the 10F Sheath and Dilator Set?

10F Sheath and Dilator Set is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K233432.

When did 10F Sheath and Dilator Set receive FDA 510(k) clearance?

10F Sheath and Dilator Set received FDA 510(k) clearance on 2023-12-08, under 510(k) number K233432.

Who is the listed applicant for 10F Sheath and Dilator Set?

The FDA 510(k) record lists Argon Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 10F Sheath and Dilator Set?

The FDA product code for 10F Sheath and Dilator Set is DYB.

Essais cliniques associés

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Dispositifs connexes (Code : DYB)

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Source officielle

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