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FDA 510(k)

12F Tri-Flow Triple Lumen Catheter

K-Number: K181175 · 2018-07-05

ApplicantMedical Components, Inc. (dba MedComp)
Decision Date2018-07-05
Product CodeNIE
Advisory CommitteeGU
DecisionUnknown

Device Summary

12F Tri-Flow Triple 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 2018-07-05 under 510(k) number K181175. The device is classified under product code NIE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the 12F Tri-Flow Triple Lumen Catheter?

12F Tri-Flow Triple Lumen Catheter is a medical device that received FDA 510(k) clearance on 2018-07-05. The listed applicant is Medical Components, Inc. (dba MedComp). The 510(k) number is K181175.

When did 12F Tri-Flow Triple Lumen Catheter receive FDA 510(k) clearance?

12F Tri-Flow Triple Lumen Catheter received FDA 510(k) clearance on 2018-07-05, under 510(k) number K181175.

Who is the listed applicant for 12F Tri-Flow Triple 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 12F Tri-Flow Triple Lumen Catheter?

The FDA product code for 12F Tri-Flow Triple Lumen Catheter is NIE.

Related Clinical Trials

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NCT07585188Neonatal Catheter Lock for Infection PreventionNOT_YET_RECRUITING

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 SideholesK192807Duo-Flow Side x Side Double Lumen CatheterK183219Trio-CT 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: NIE)

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 ExtensionsMedical Components, Inc. (dba MedComp)K222170Power Acute Triple Lumen Hemodialysis CatheterHealth Line International CorporationK183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)

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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