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FDA 510(k)

VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set

K-Number: K173757 · 2018-04-19

ApplicantGreiner Bio-One Na, Inc.
Decision Date2018-04-19
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set 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 2018-04-19 under 510(k) number K173757. 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 EVOPROTECT Safety Blood Collection / Infusion Set?

VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Greiner Bio-One Na, Inc.. The 510(k) number is K173757.

When did VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set receive FDA 510(k) clearance?

VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set received FDA 510(k) clearance on 2018-04-19, under 510(k) number K173757.

Who is the listed applicant for VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set?

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 EVOPROTECT Safety Blood Collection / Infusion Set?

The FDA product code for VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set 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.

NCT07083830ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) TransplantsNOT_YET_RECRUITING

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 TubesK180545VACUETTE SAFELINK Holder with male luer lockK163436Greiner 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

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