The following data is part of a premarket notification filed by Arch Catheter, Llc with the FDA for Gatekeeper Balloon Catheter.
|Device Name:||Gatekeeper Balloon Catheter|
|Classification||Catheter, Intravascular Occluding, Temporary|
|Applicant||Arch Catheter, LLC 621 Grand Harbor Boulevard Ninety Six, SC 29666|
Medical Device Academy 345 Lincoln Hill Rd. Shrewsbury, VT 05738
|CFR Regulation Number||870.4450 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|