# Mivi Neuroscience, Inc.

- Location (FDA's records): Eden Prarie, MN
- FDA decisions: 5 (2015–2023): 5 510(k) clearances
- Product codes: DQY (2), QJP (2), MOF (1)
- 510(k) review time since 2016: median 140 days, against 139 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mivi Neurovascular: 2 (https://510kreport.com/company/mivi-neurovascular)
- Mivi, LLC: 1 (https://510kreport.com/company/mivi)
- Penumbra, Inc.: 1 (https://510kreport.com/company/penumbra)
- Codman & Shurtleff, Inc.: 1 (https://510kreport.com/company/codman-shurtleff)

## Firms that cite its devices most
- Mivi Neurovascular: 1 (https://510kreport.com/company/mivi-neurovascular)
- Aqure Medical, Inc.: 1 (https://510kreport.com/company/aqure-medical)
- Route 92 Medical, Inc.: 1 (https://510kreport.com/company/route-92-medical)

## Its most-cited devices
- K163233: MIVI 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 Catheter (2017), cited by 2
- K151396: MIVI Mi-AXUS Guide Catheter (2015), cited by 1

## Recent decisions
- K222948: Q Distal Access Catheter (Sep 19, 2023)
- K212402: MIVI Q Distal Access Catheter (Dec 16, 2021)
- K163233: MIVI 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 Catheter (Apr 6, 2017)
- K151396: MIVI Mi-AXUS Guide Catheter (Dec 9, 2015)
- K151825: Viradius Neurowire (Nov 16, 2015)

Source page: https://510kreport.com/company/mivi-neuroscience