LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE

Set, Administration, Intravascular

STRATO MEDICAL CORP.

The following data is part of a premarket notification filed by Strato Medical Corp. with the FDA for Lifeport Infusion Set And Infusion Set W/ Y Site.

Pre-market Notification Details

Device IDK921674
510k NumberK921674
Device Name:LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE
ClassificationSet, Administration, Intravascular
Applicant STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly,  MA  01915
ContactNancy C Hall
CorrespondentNancy C Hall
STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly,  MA  01915
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-08
Decision Date1992-09-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H787LPS30255 K921674 000
H787LPS30235 K921674 000
H787LPS30175 K921674 000
H787LPS30095 K921674 000
H787LPS30085 K921674 000
H787LPS30075 K921674 000
H787LPS30065 K921674 000
H787LPS30055 K921674 000
H787LPS30045 K921674 000

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