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FDA 510(k)

Duo-Flow Side x Side Double Lumen Catheter

K-Number: K192807 · 2020-04-23

ApplicantMedical Components, Inc. (dba MedComp)
Decision Date2020-04-23
Product CodeMPB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Duo-Flow Side x Side Double Lumen Catheter is a medical device manufactured by Medical Components, Inc. (dba MedComp). It received FDA 510(k) clearance on 2020-04-23 under approval number K192807. 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 Duo-Flow Side x Side Double Lumen Catheter?

Duo-Flow Side x Side Double Lumen Catheter is a medical device that received FDA 510(k) clearance on 2020-04-23. It is manufactured by Medical Components, Inc. (dba MedComp). The 510(k) number is K192807.

When was Duo-Flow Side x Side Double Lumen Catheter approved by the FDA?

Duo-Flow Side x Side Double Lumen Catheter received FDA 510(k) clearance on 2020-04-23, under approval number K192807.

What company makes Duo-Flow Side x Side Double Lumen Catheter?

Duo-Flow Side x Side Double Lumen Catheter is manufactured by Medical Components, Inc. (dba MedComp).

What is the FDA product code for Duo-Flow Side x Side Double Lumen Catheter?

The FDA product code for 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

Other Devices by Medical Components, Inc. (dba MedComp)

K170770CT Midline K18117512F Tri-Flow Triple Lumen Catheter K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes K180567C3 Wave System K183219Trio-CT Triple Lumen Catheter K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes

View all 8 devices →

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 K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLC K25083614F Duo-Flow® Side X Side Double Lumen CatheterMedical Components, 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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