Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VACUETTE SAFELINK Holder with male luer lock

K-Number: K180545 · 2018-05-21

ApplicantGreiner Bio-One Na, Inc.
Decision Date2018-05-21
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VACUETTE SAFELINK Holder with male luer lock is the device name listed in this FDA 510(k) record. The listed applicant is Greiner Bio-One Na, Inc.. It received FDA 510(k) clearance on 2018-05-21 under 510(k) number K180545. 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 VACUETTE SAFELINK Holder with male luer lock?

VACUETTE SAFELINK Holder with male luer lock is a medical device that received FDA 510(k) clearance on 2018-05-21. The listed applicant is Greiner Bio-One Na, Inc.. The 510(k) number is K180545.

When did VACUETTE SAFELINK Holder with male luer lock receive FDA 510(k) clearance?

VACUETTE SAFELINK Holder with male luer lock received FDA 510(k) clearance on 2018-05-21, under 510(k) number K180545.

Who is the listed applicant for VACUETTE SAFELINK Holder with male luer lock?

The FDA 510(k) record lists Greiner Bio-One Na, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VACUETTE SAFELINK Holder with male luer lock?

The FDA product code for VACUETTE SAFELINK Holder with male luer lock is FMI.

Other records listing Greiner Bio-One Na, Inc. 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.

K182078MiniCollect K2E K2EDTA TubesK173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetK163436Greiner Vacuette Urine Count and Culture, Mannitol tubeK160532Greiner Holdex

Related Devices (Code: FMI)

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.

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.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech 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.

↑