FDA 510(k)

Huber Needle Infusion Set, Safety Huber Needle Infusion Set

K-Number: K200463 · 2021-04-07

Decision Date2021-04-07

Product CodePTI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Huber Needle Infusion Set, Safety Huber Needle Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2021-04-07 under 510(k) number K200463. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Huber Needle Infusion Set, Safety Huber Needle Infusion Set?

Huber Needle Infusion Set, Safety Huber Needle Infusion Set is a medical device that received FDA 510(k) clearance on 2021-04-07. The listed applicant is Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K200463.

When did Huber Needle Infusion Set, Safety Huber Needle Infusion Set receive FDA 510(k) clearance?

Huber Needle Infusion Set, Safety Huber Needle Infusion Set received FDA 510(k) clearance on 2021-04-07, under 510(k) number K200463.

Who is the listed applicant for Huber Needle Infusion Set, Safety Huber Needle Infusion Set?

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

What is the FDA product code for Huber Needle Infusion Set, Safety Huber Needle Infusion Set?

The FDA product code for Huber Needle Infusion Set, Safety Huber Needle Infusion Set is PTI.

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Official Source

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