FDA.reportPublic FDA data

Mivi Neuroscience Inc

Matched from indexed company URL: MIVI, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30114105093011410509Mivi Neuroscience Inc1N2020-04-256545 City West Pkwy Eden Prairie MN US 55344

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1793301265366994K163233MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension CatheterDQY2017-04-06
1793301731736260K151825Viradius NeurowireMOF2015-11-16
1793302050650996K151396MIVI Mi-AXUS Guide CatheterDQY2015-12-09
1793301404272555K140557MIVI 6F GUIDE CATHETERDQY2014-09-18
1793301230571274
1793301987454968

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQY32017-04-06
MOF12015-11-16

PMN#

GUDID#

Mi-Axus Catheter - The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter designed for use in facilitating the insertion and guidance of micro catheters into a selected blood vessel in the peripheral, coronary, or neuro vascular system. A radiopaque marker is included on the distal end. The catheter shaft has a hydrophilic coating. The proximal segment is constructed with Vestamid. The distal segment of the PEBAX is impregnated with barium sulphate for increased radiopacity.

MIVI NEUROVASCULAR

2017-03-15

Mi-Axus Catheter - The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter designed for use in facilitating the insertion and guidance of micro catheters into a selected blood vessel in the peripheral, coronary, or neuro vascular system. A radiopaque marker is included on the distal end. The catheter shaft has a hydrophilic coating. The proximal segment is constructed with Vestamid. The distal segment of the PEBAX is impregnated with barium sulphate for increased radiopacity.

MIVI NEUROVASCULAR

2017-03-15

Mi-Axus Catheter - The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter designed for use in facilitating the insertion and guidance of micro catheters into a selected blood vessel in the peripheral, coronary, or neuro vascular system. A radiopaque marker is included on the distal end. The catheter shaft has a hydrophilic coating. The proximal segment is constructed with Vestamid. The distal segment of the PEBAX is impregnated with barium sulphate for increased radiopacity.

MIVI NEUROVASCULAR

2018-02-23