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FDA 510(k)

MC3 Jugular Dual Lumen Catheter

K-Number: K180151 · 2018-07-16

ApplicantMc3 Incorporated
Decision Date2018-07-16
Product CodePZS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MC3 Jugular Dual Lumen Catheter is a medical device manufactured by Mc3 Incorporated. It received FDA 510(k) clearance on 2018-07-16 under approval number K180151. The device is classified under product code PZS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MC3 Jugular Dual Lumen Catheter?

MC3 Jugular Dual Lumen Catheter is a medical device that received FDA 510(k) clearance on 2018-07-16. It is manufactured by Mc3 Incorporated. The 510(k) number is K180151.

When was MC3 Jugular Dual Lumen Catheter approved by the FDA?

MC3 Jugular Dual Lumen Catheter received FDA 510(k) clearance on 2018-07-16, under approval number K180151.

What company makes MC3 Jugular Dual Lumen Catheter?

MC3 Jugular Dual Lumen Catheter is manufactured by Mc3 Incorporated.

What is the FDA product code for MC3 Jugular Dual Lumen Catheter?

The FDA product code for MC3 Jugular Dual Lumen Catheter is PZS.

Related Clinical Trials

NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07585188 Neonatal Catheter Lock for Infection Prevention NOT_YET_RECRUITING NCT07219758 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK) RECRUITING NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING NCT02633124 Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants. TERMINATED

Other Devices by Mc3 Incorporated

K171610MC3 QuickFlow Dual Lumen Catheter K182914MC3 Vascular Access Kit 21030 K191935Nautilus Smart ECMO Module

Related Devices (Code: PZS)

K171610MC3 QuickFlow Dual Lumen CatheterMc3 Incorporated K203409MC3 Crescent Jugular Dual Lumen CatheterMc3, Inc. K232480ProtekDuo Veno-Venous Cannula SetsCardiacassist, 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.

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