FDA 510(k)

NON-CORING NEEDLE

K-Number: K961088 · 1996-07-02

Decision Date1996-07-02

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NON-CORING NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 1996-07-02 under 510(k) number K961088. 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 NON-CORING NEEDLE?

NON-CORING NEEDLE is a medical device that received FDA 510(k) clearance on 1996-07-02. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K961088.

When did NON-CORING NEEDLE receive FDA 510(k) clearance?

NON-CORING NEEDLE received FDA 510(k) clearance on 1996-07-02, under 510(k) number K961088.

Who is the listed applicant for NON-CORING NEEDLE?

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

What is the FDA product code for NON-CORING NEEDLE?

The FDA product code for NON-CORING NEEDLE is FMI.

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Other records listing Arrow Intl., Inc. as applicant

K100635ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 K093050ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 K071491ARROW INTERNATIONAL, INC., SURGICAL DRAPES K071998ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT K071111NON-ABSORBABLE SILK SUTURE K060309AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.