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FDA 510(k)

ISP Safety Huber Needle Infusion Set

K-Number: K170881 · 2017-12-14

ApplicantInfusion Safety Products, Inc.
Decision Date2017-12-14
Product CodePTI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ISP Safety Huber Needle Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Infusion Safety Products, Inc.. It received FDA 510(k) clearance on 2017-12-14 under 510(k) number K170881. 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 ISP Safety Huber Needle Infusion Set?

ISP Safety Huber Needle Infusion Set is a medical device that received FDA 510(k) clearance on 2017-12-14. The listed applicant is Infusion Safety Products, Inc.. The 510(k) number is K170881.

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

ISP Safety Huber Needle Infusion Set received FDA 510(k) clearance on 2017-12-14, under 510(k) number K170881.

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

The FDA 510(k) record lists Infusion Safety Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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.K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.K213823Intera Refill KitIntera Oncology, Inc.

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.

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