DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER

Catheter, Retention Type, Balloon

TYCO HEALTHCARE

The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Dover Silver Temperature Sensing Foley Catheter.

Pre-market Notification Details

Device IDK042709
510k NumberK042709
Device Name:DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
ClassificationCatheter, Retention Type, Balloon
Applicant TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield,  MA  02048
ContactWei Zhao
CorrespondentWei Zhao
TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield,  MA  02048
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2004-09-30
Decision Date2005-01-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521149236 K042709 000
10884521149229 K042709 000

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