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FDA 510(k)

14F Duo-Flow® Side X Side Double Lumen Catheter

K-Number: K250836 · 2025-08-12

ApplicantMedical Components, Inc.
Decision Date2025-08-12
Product CodeMPB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

14F Duo-Flow® Side X Side Double Lumen Catheter is a medical device manufactured by Medical Components, Inc.. It received FDA 510(k) clearance on 2025-08-12 under approval number K250836. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 14F Duo-Flow® Side X Side Double Lumen Catheter?

14F Duo-Flow® Side X Side Double Lumen Catheter is a medical device that received FDA 510(k) clearance on 2025-08-12. It is manufactured by Medical Components, Inc.. The 510(k) number is K250836.

When was 14F Duo-Flow® Side X Side Double Lumen Catheter approved by the FDA?

14F Duo-Flow® Side X Side Double Lumen Catheter received FDA 510(k) clearance on 2025-08-12, under approval number K250836.

What company makes 14F Duo-Flow® Side X Side Double Lumen Catheter?

14F Duo-Flow® Side X Side Double Lumen Catheter is manufactured by Medical Components, Inc..

What is the FDA product code for 14F Duo-Flow® Side X Side Double Lumen Catheter?

The FDA product code for 14F Duo-Flow® Side X Side Double Lumen Catheter is MPB.

Related Clinical Trials

NCT07614529 Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation NOT_YET_RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED NCT07585188 Neonatal Catheter Lock for Infection Prevention NOT_YET_RECRUITING NCT06375967 EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial) SUSPENDED NCT07219758 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK) RECRUITING

Related Devices (Code: MPB)

K153190Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc. K163458Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc. K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook Incorporated K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation K192807Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (dba MedComp) K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLC

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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