FLUME Catheter

Catheter, Retention Type, Balloon

The Flume Catheter Company, Ltd.

The following data is part of a premarket notification filed by The Flume Catheter Company, Ltd. with the FDA for Flume Catheter.

Pre-market Notification Details

Device IDK212151
510k NumberK212151
Device Name:FLUME Catheter
ClassificationCatheter, Retention Type, Balloon
Applicant The Flume Catheter Company, Ltd. The Granary, Millhouse Frensham,  GB Gu10 3ee
ContactRoger Holmes
CorrespondentElaine Duncan
Paladin Medical, Inc. PO Box 560 Stillwater,  MN  55082
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-09
Decision Date2021-11-03

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