The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Swiftninja Steerable Microcatheter.
|Device Name:||SwiftNINJA Steerable Microcatheter|
|Classification||Catheter, Continuous Flush|
|Applicant||Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095|
Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095
|CFR Regulation Number||870.1210 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|