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FDA 510(k)

FLUME catheter

K-Number: K212151 · 2021-11-03

ApplicantThe Flume Catheter Company, Ltd.
Decision Date2021-11-03
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLUME catheter is a medical device manufactured by The Flume Catheter Company, Ltd.. It received FDA 510(k) clearance on 2021-11-03 under approval number K212151. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUME catheter?

FLUME catheter is a medical device that received FDA 510(k) clearance on 2021-11-03. It is manufactured by The Flume Catheter Company, Ltd.. The 510(k) number is K212151.

When was FLUME catheter approved by the FDA?

FLUME catheter received FDA 510(k) clearance on 2021-11-03, under approval number K212151.

What company makes FLUME catheter?

FLUME catheter is manufactured by The Flume Catheter Company, Ltd..

What is the FDA product code for FLUME catheter?

The FDA product code for FLUME catheter is EZL.

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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.

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