REFLEXION SPIRAL VARIABLE RADIUS CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

ST. JUDE MEDICAL

The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Reflexion Spiral Variable Radius Catheter.

Pre-market Notification Details

Device IDK072012
510k NumberK072012
Device Name:REFLEXION SPIRAL VARIABLE RADIUS CATHETER
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka,  MN  55345 -2126
ContactLaura Moen-ftacek
CorrespondentLaura Moen-ftacek
ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka,  MN  55345 -2126
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-23
Decision Date2007-08-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05414734216654 K072012 000
05414734206211 K072012 000

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