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)

BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes

K-Number: K213670 · 2023-08-25

ApplicantBecton, Dickinson and Company
Decision Date2023-08-25
Product CodeGIM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2023-08-25 under approval number K213670. The device is classified under product code GIM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes?

BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes is a medical device that received FDA 510(k) clearance on 2023-08-25. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K213670.

When was BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes approved by the FDA?

BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes received FDA 510(k) clearance on 2023-08-25, under approval number K213670.

What company makes BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes?

BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes?

The FDA product code for BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes is GIM.

Related Clinical Trials

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 NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT06915012 Impact of Biophoton Therapy on Chronic Severe Arthritis Pain RECRUITING NCT07595068 Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases NOT_YET_RECRUITING NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING NCT07587294 Efficacy and Safety of Ultrasound Modulation of Stellate Ganglion for the Prevention of Ventricular Arrhythmia in Patients With ST-segment Elevation Myocardial Infarction NOT_YET_RECRUITING

Other Devices by Becton, Dickinson and Company

K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe K162516BD Pen Needle K160657BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube K151589BD MAX CT/GC/TV, BD MAX INSTRUMENT K151870BD U-500 INSULIN SYRINGE K161553BD SafeAssist

View all 100 devices →

Related Devices (Code: GIM)

K162723TransFix/EDTA Vacuum Blood Collection TubesCaltag Medsystems, Ltd. K230493BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection TubeBecton, Dickinson and Company K240455BD Vacutainer® Citrate Blood Collection TubesBecton, Dickinson and Company

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.

↑