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

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 a medical device manufactured by Greiner Bio-One Na, Inc.. It received FDA 510(k) clearance on 2018-04-19 under approval 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. It is manufactured by Greiner Bio-One Na, Inc.. The 510(k) number is K173757.

When was VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set approved by the FDA?

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

What company makes VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set?

VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set is manufactured by Greiner Bio-One Na, Inc..

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

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT06153667 Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE) RECRUITING NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT06872905 Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease RECRUITING NCT07615959 Medicsen Smartpatch: Safety & Performance (SOUNDD) ACTIVE_NOT_RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING

Related PubMed Literature

PMID: 41322758 Real-World Case Series on Surgi-ORC® in ENT Surgery. Cureus (2025) PMID: 41085780 Evaluation of nickel release from Ni-Ti stents in various media for safety assessment purposes. Journal of materials science. Materials in medicine (2025)

Other Devices by Greiner Bio-One Na, Inc.

K160532Greiner Holdex K163436Greiner Vacuette Urine Count and Culture, Mannitol tube K180545VACUETTE SAFELINK Holder with male luer lock K182078MiniCollect K2E K2EDTA Tubes

Related Devices (Code: FMI)

K162516BD Pen NeedleBecton, Dickinson and Company K160532Greiner HoldexGreiner Bio-One Na, Inc. K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. K151090CPL Insulin Pen NeedleCpl Co., Ltd. K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.

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.

↑