PROWLER SELECT PLUS; PROWLER EX

Catheter, Continuous Flush

Medos International SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Prowler Select Plus; Prowler Ex.

Pre-market Notification Details

Device IDK210838
510k NumberK210838
Device Name:PROWLER SELECT PLUS; PROWLER EX
ClassificationCatheter, Continuous Flush
Applicant Medos International SARL Chemin-Blanc 38 Le Locle,  CH 2400
ContactSamuel Shimp
CorrespondentSamuel Shimp
Cerenovus 6303 Blue Lagoon Drive; Suite 315 Miami,  FL  33126
Product CodeKRA  
Subsequent Product CodeDQY
Subsequent Product CodeQJP
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-22
Decision Date2021-08-25

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