MIVI Mi-AXUS Guide Catheter— 510(k) K151396
Substantially EquivalentMivi Neuroscience, Inc.
FDA 510(k) clearance K151396 for MIVI Mi-AXUS Guide Catheter, Substantially Equivalent on 2015-12-09. Applicant: Mivi Neuroscience, Inc.. Device class: 2.
Clearance details
- Applicant
- Mivi Neuroscience, Inc.
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prarie, MN, US
Recent devices under product code DQY
view allMore clearances from Mivi Neuroscience, Inc.
view allAdverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K151396
K-number listed on FDA's recall record- 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.
- 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151396.
Data sourced from openFDA. This site is unofficial and independent of the FDA.