ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL

Catheter, Continuous Flush

ST. JUDE MEDICAL

The following data is part of a premarket notification filed by St. Jude Medical with the FDA for St Jude Medical, Is4 Flushing/funneling Tool.

Pre-market Notification Details

Device IDK113773
510k NumberK113773
Device Name:ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL
ClassificationCatheter, Continuous Flush
Applicant ST. JUDE MEDICAL 15900 Valley View Court Sylmar,  CA  91342
ContactGeena George
CorrespondentGeena George
ST. JUDE MEDICAL 15900 Valley View Court Sylmar,  CA  91342
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-22
Decision Date2012-01-18
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.