FDA 510(k)

FLUME catheter

Numéro K : K212151 · 2021-11-03

DemandeurThe Flume Catheter Company, Ltd.

Date de décision2021-11-03

Code produitEZL

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Source officielle

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