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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 a medical device manufactured by Infusion Safety Products, Inc.. It received FDA 510(k) clearance on 2017-12-14 under approval 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. It is manufactured by Infusion Safety Products, Inc.. The 510(k) number is K170881.

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

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

What company makes ISP Safety Huber Needle Infusion Set?

ISP Safety Huber Needle Infusion Set is manufactured by Infusion Safety Products, Inc..

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 Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT06000540 Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects NOT_YET_RECRUITING NCT06204614 Drug Screening Using IMD in Bladder Cancer ENROLLING_BY_INVITATION NCT05231278 Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy COMPLETED NCT07575191 Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer NOT_YET_RECRUITING

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)

Related Devices (Code: PTI)

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. K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd

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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