LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN

Catheter, Steerable

ST. JUDE MEDICAL

The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Luminary Cannulator Bideflectable Catheter With Lumen.

Pre-market Notification Details

Device IDK052575
510k NumberK052575
Device Name:LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
ClassificationCatheter, Steerable
Applicant ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka,  MN  55345 -2126
ContactPatrice Stromberg
CorrespondentPatrice Stromberg
ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka,  MN  55345 -2126
Product CodeDRA  
CFR Regulation Number870.1280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-19
Decision Date2006-01-19
Summary:summary

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