NIPRO SAFELET CATH

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

NIPRO MEDICAL CORP.

The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Safelet Cath.

Pre-market Notification Details

Device IDK013287
510k NumberK013287
Device Name:NIPRO SAFELET CATH
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant NIPRO MEDICAL CORP. 1384 COPPERFIELD COURT Lexington,  KY  40514 -1268
ContactKaelyn B Hadley
CorrespondentKaelyn B Hadley
NIPRO MEDICAL CORP. 1384 COPPERFIELD COURT Lexington,  KY  40514 -1268
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-02
Decision Date2001-12-03
Summary:summary

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