FDA 510(k)

VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES

K-Number: K884792 · 1989-01-30

Decision Date1989-01-30

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Infucare Products, Inc.. It received FDA 510(k) clearance on 1989-01-30 under 510(k) number K884792. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES?

VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES is a medical device that received FDA 510(k) clearance on 1989-01-30. The listed applicant is Infucare Products, Inc.. The 510(k) number is K884792.

When did VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES receive FDA 510(k) clearance?

VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES received FDA 510(k) clearance on 1989-01-30, under 510(k) number K884792.

Who is the listed applicant for VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES?

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

What is the FDA product code for VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES?

The FDA product code for VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES is FMI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Infucare Products, Inc. as applicant

K914034INFUCARE SYRINGE PUMP TUBING SET K891226VASCULAR ACCESS PORT CONTINUOUS INFUSION SET

Related Devices (Code: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., 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.