The following data is part of a premarket notification filed by Marvao Medical Devices Ltd with the FDA for Boss Crossing Support Catheter.
|Device Name:||Boss Crossing Support Catheter|
|Applicant||Marvao Medical Devices Ltd Unit 1 Galway Business Park, Dangan Galway, IE H91A3EF|
|Correspondent||Mary P. LeGraw|
Avania Ltd 100 Crowley Drive, Suite 216 Marlborough, MA 01752
|CFR Regulation Number||870.1250 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|