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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 the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc. (dba MedComp). It received FDA 510(k) clearance on 2020-04-23 under 510(k) 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. The listed applicant is Medical Components, Inc. (dba MedComp). The 510(k) number is K192807.

When did Duo-Flow Side x Side Double Lumen Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Duo-Flow Side x Side Double Lumen Catheter?

The FDA 510(k) record lists Medical Components, Inc. (dba MedComp) as the applicant. This does not by itself establish the device manufacturer.

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

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Other records listing Medical Components, Inc. (dba MedComp) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsK202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesK183219Trio-CT Triple Lumen CatheterK18117512F Tri-Flow Triple Lumen CatheterK17366715.5F 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 SideholesK180567C3 Wave System

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Related Devices (Code: MPB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K25083614F Duo-Flow® Side X Side Double Lumen CatheterMedical Components, Inc.K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International CorporationK192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLCK163458Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook IncorporatedK153190Zenysis Short-Term Dialysis CatheterC.R. Bard, 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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