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FDA 510(k)

Trio-CT Triple Lumen Catheter

K-Number: K183219 · 2019-06-14

ApplicantMedical Components, Inc. (dba MedComp)
Decision Date2019-06-14
Product CodeNIE
Advisory CommitteeGU
DecisionUnknown

Device Summary

Trio-CT Triple Lumen Catheter is a medical device manufactured by Medical Components, Inc. (dba MedComp). It received FDA 510(k) clearance on 2019-06-14 under approval number K183219. 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 Trio-CT Triple Lumen Catheter?

Trio-CT Triple Lumen Catheter is a medical device that received FDA 510(k) clearance on 2019-06-14. It is manufactured by Medical Components, Inc. (dba MedComp). The 510(k) number is K183219.

When was Trio-CT Triple Lumen Catheter approved by the FDA?

Trio-CT Triple Lumen Catheter received FDA 510(k) clearance on 2019-06-14, under approval number K183219.

What company makes Trio-CT Triple Lumen Catheter?

Trio-CT Triple Lumen Catheter is manufactured by Medical Components, Inc. (dba MedComp).

What is the FDA product code for Trio-CT Triple Lumen Catheter?

The FDA product code for Trio-CT Triple Lumen Catheter is NIE.

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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 K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes K192807Duo-Flow Side x Side Double Lumen Catheter

View all 8 devices →

Related Devices (Code: NIE)

K18117512F Tri-Flow Triple Lumen CatheterMedical Components, Inc. (dba MedComp) K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp) K222170Power Acute Triple Lumen Hemodialysis CatheterHealth Line International Corporation

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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