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FDA 510(k)

12F Tri-Flow Triple Lumen Catheter

K-Number: K181175 · 2018-07-05

Decision Date2018-07-05
Product CodeNIE
Advisory CommitteeGU
DecisionUnknown

Device Summary

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

When was 12F Tri-Flow Triple Lumen Catheter approved by the FDA?

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

What company makes 12F Tri-Flow Triple Lumen Catheter?

12F Tri-Flow Triple Lumen Catheter is manufactured by Medical Components, Inc. (dba MedComp).

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.

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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.