Rusch Simplastic Foley Catheters

Catheter, Retention Type, Balloon

TELEFLEX MEDICAL, INC.

The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Rusch Simplastic Foley Catheters.

Pre-market Notification Details

Device IDK162989
510k NumberK162989
Device Name:Rusch Simplastic Foley Catheters
ClassificationCatheter, Retention Type, Balloon
Applicant TELEFLEX MEDICAL, INC. 3015 CARRINGTON MILLS BLVD Morrisville,  NC  27560
ContactLori Pfohl
CorrespondentLori Pfohl
TELEFLEX MEDICAL, INC. 3015 CARRINGTON MILLS BLVD Morrisville,  NC  27560
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-27
Decision Date2017-02-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
34026704612551 K162989 000
24026704612387 K162989 000
24026704612394 K162989 000
24026704612400 K162989 000
34026704612421 K162989 000
24026704612431 K162989 000
24026704612448 K162989 000
34026704612452 K162989 000
24026704612462 K162989 000
24026704612479 K162989 000
24026704612486 K162989 000
24026704612493 K162989 000
34026704612506 K162989 000
24026704612516 K162989 000
34026704612377 K162989 000

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