FDA 510(k)

Système d'accès port stérile unique d'utilisation médicale AFS

Numéro K : K202688 · 2021-10-14

Date de décision2021-10-14

Code produitOTJ

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

AFS Medical Sterile Single-Use Access Port System is the device name listed in this FDA 510(k) record. The listed applicant is Afs Medical Co. , Ltd.. It received FDA 510(k) clearance on 2021-10-14 under 510(k) number K202688. The device is classified under product code OTJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the AFS Medical Sterile Single-Use Access Port System?

AFS Medical Sterile Single-Use Access Port System is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Afs Medical Co. , Ltd.. The 510(k) number is K202688.

When did AFS Medical Sterile Single-Use Access Port System receive FDA 510(k) clearance?

AFS Medical Sterile Single-Use Access Port System received FDA 510(k) clearance on 2021-10-14, under 510(k) number K202688.

Who is the listed applicant for AFS Medical Sterile Single-Use Access Port System?

The FDA 510(k) record lists Afs Medical Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFS Medical Sterile Single-Use Access Port System?

The FDA product code for AFS Medical Sterile Single-Use Access Port System is OTJ.

Essais cliniques associés

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Dispositifs connexes (Code : OTJ)

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Source officielle

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