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)

Kurin Blood Culture Collection Set

K-Number: K162233 · 2016-12-23

ApplicantPathway, LLC
Decision Date2016-12-23
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Kurin Blood Culture Collection Set is a medical device manufactured by Pathway, LLC. It received FDA 510(k) clearance on 2016-12-23 under approval number K162233. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kurin Blood Culture Collection Set?

Kurin Blood Culture Collection Set is a medical device that received FDA 510(k) clearance on 2016-12-23. It is manufactured by Pathway, LLC. The 510(k) number is K162233.

When was Kurin Blood Culture Collection Set approved by the FDA?

Kurin Blood Culture Collection Set received FDA 510(k) clearance on 2016-12-23, under approval number K162233.

What company makes Kurin Blood Culture Collection Set?

Kurin Blood Culture Collection Set is manufactured by Pathway, LLC.

What is the FDA product code for Kurin Blood Culture Collection Set?

The FDA product code for Kurin Blood Culture Collection Set is JKA.

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 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 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 NCT06968845 A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis RECRUITING NCT07573059 Evaluation of the Safety of Loargys Arginine Test System in Loargys-treated Patients RECRUITING

Other Devices by Pathway, LLC

K181616PSM 3-Way Silicone Foley Catheter K192034HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc

Related Devices (Code: JKA)

K160657BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection TubeBecton, Dickinson and Company K153309BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company K152924TIVA¿Velano Vascular K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached HolderSol-Millennium Medical, Inc. K163508PIVOVelano Vascular K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with HolderZhejiang Kindly Medical Devices 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.

↑