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FDA 510(k)

AFS Medical Sterile Single-Use Access Port System

K-Number: K202688 · 2021-10-14

ApplicantAfs Medical Co. , Ltd.
Decision Date2021-10-14
Product CodeOTJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Afs Medical Co. , Ltd.. The 510(k) number is K202688.

When was AFS Medical Sterile Single-Use Access Port System approved by the FDA?

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

What company makes AFS Medical Sterile Single-Use Access Port System?

AFS Medical Sterile Single-Use Access Port System is manufactured by Afs Medical Co. , Ltd..

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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