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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 the device name listed in this FDA 510(k) record. The listed applicant is The Flume Catheter Company, Ltd.. It received FDA 510(k) clearance on 2021-11-03 under 510(k) 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. The listed applicant is The Flume Catheter Company, Ltd.. The 510(k) number is K212151.

When did FLUME catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for FLUME catheter?

The FDA 510(k) record lists The Flume Catheter Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLUME catheter?

The FDA product code for FLUME catheter is EZL.

Related Devices (Code: EZL)

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.

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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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