Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D

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 Advisor Fl 15mm 12 Pole 333 Uni D, Advisor Fl 20mm 12 Pole 555 Uni D, Advisor Fl 15mm 12 Pole 333 Bi D, Advisor Fl 20mm 12 Pole 555 Bi D.

Pre-market Notification Details

Device IDK160335
510k NumberK160335
Device Name:Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant St. Jude Medical 5050 Nathan Lane Plymouth,  MN  55442
ContactTamara Stanczak
CorrespondentTamara Stanczak
St. Jude Medical 5050 Nathan Lane Plymouth,  MN  55442
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-08
Decision Date2016-12-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05415067025975 K160335 000
05415067025968 K160335 000
05415067024817 K160335 000
05415067024800 K160335 000

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