Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled

Catheter, Recording, Electrode, Reprocessed

Stryker Sustainability Solutions

The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Reprocessed Advisor Fl Circular Mapping Catheter, Sensor Enabled.

Pre-market Notification Details

Device IDK200205
510k NumberK200205
Device Name:Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled
ClassificationCatheter, Recording, Electrode, Reprocessed
Applicant Stryker Sustainability Solutions 1810 W Drake Drive Tempe,  AZ  85283
ContactMia Mccorkel
CorrespondentMia Mccorkel
Stryker Sustainability Solutions 1810 W Drake Drive Tempe,  AZ  85283
Product CodeNLH  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-28
Decision Date2020-05-13

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