Mivi Neuroscience, Inc.
Mivi Neuroscience, Inc. holds FDA 510(k) medical device clearances, first cleared 2015, most recent 2023, with 2 FDA device recalls on record.
Top product codes for Mivi Neuroscience, Inc.
FDA recalls by Mivi Neuroscience, Inc.
- Z-2442-2021 — MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
- Z-2441-2021 — MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Mivi Neuroscience, Inc.
- K222948 — Q Distal Access Catheter
- K212402 — MIVI Q Distal Access Catheter
- 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
- K151396 — MIVI Mi-AXUS Guide Catheter
- K151825 — Viradius Neurowire
Data sourced from openFDA. This site is unofficial and independent of the FDA.