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FDA 510(k)

Promisemed Safety Huber Needle

K-Number: K230715 · 2023-06-08

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2023-06-08
Product CodePTI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Promisemed Safety Huber Needle is the device name listed in this FDA 510(k) record. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2023-06-08 under 510(k) number K230715. 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 Promisemed Safety Huber Needle?

Promisemed Safety Huber Needle is a medical device that received FDA 510(k) clearance on 2023-06-08. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K230715.

When did Promisemed Safety Huber Needle receive FDA 510(k) clearance?

Promisemed Safety Huber Needle received FDA 510(k) clearance on 2023-06-08, under 510(k) number K230715.

Who is the listed applicant for Promisemed Safety Huber Needle?

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

What is the FDA product code for Promisemed Safety Huber Needle?

The FDA product code for Promisemed Safety Huber Needle is PTI.

Other records listing Promisemed Hangzhou Meditech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: PTI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSb-Kawasumi Laboratories, Inc.K251138Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.K243332Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetBard Access Systems, Inc.K213823Intera Refill KitIntera Oncology, 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.

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