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 a medical device manufactured by Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2021-04-07 under approval 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. It is manufactured by Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K200463.

When was Huber Needle Infusion Set, Safety Huber Needle Infusion Set approved by the FDA?

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

What company makes Huber Needle Infusion Set, Safety Huber Needle Infusion Set?

Huber Needle Infusion Set, Safety Huber Needle Infusion Set is manufactured by Jiangsu Caina Medical Co.,Ltd.

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Jiangsu Caina Medical Co.,Ltd

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Related Devices (Code: PTI)

K170881ISP Safety Huber Needle Infusion SetInfusion Safety Products, Inc. K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y siteB.Braun Medical, Inc. K171735PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetC.R. Bard, Inc. K17133320G x 5/8 Pro-Lock CT Safety Infusion SetMedcomp (Dba Medical Components, Inc.) K162271Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.) K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep KitIntera Oncology, Inc.

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.