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.
|Device Name:||Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled|
|Classification||Catheter, Recording, Electrode, Reprocessed|
|Applicant||Stryker Sustainability Solutions 1810 W Drake Drive Tempe, AZ 85283|
Stryker Sustainability Solutions 1810 W Drake Drive Tempe, AZ 85283
|CFR Regulation Number||870.1220 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|