Ev3 Neurovascular: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Ev3 Neurovascular” (first 2009, latest 2010), plus 1 PMA decision, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 60 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MJN | Catheter, Intravascular Occluding, Temporary | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| MFE | Agent, Injectable, Embolic | 1 | 0 |
Review panels
- Cardiovascular (3)
- Neurology (1)
Most recent Ev3 Neurovascular 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093681 | MERIDIAN GUIDEWIRE | DQX | 2010-01-26 | 60 |
| K091458 | HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 | MJN | 2009-10-15 | 150 |
| K092495 | HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 | MJN | 2009-09-22 | 39 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P030004 | PMA | ONYX LIQUID EMBOLIC SYSTEM | 2005-07-21 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-04-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ev3 Neurovascular?
FDA lists 3 510(k) clearances under the applicant name “Ev3 Neurovascular” (first 2009, latest 2010), plus 1 PMA decision, across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ev3 Neurovascular?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ev3 Neurovascular is 60 days.
Which FDA product codes appear under Ev3 Neurovascular?
The most frequent FDA product codes under this applicant name are MJN (Catheter, Intravascular Occluding, Temporary, 2); DQX (Wire, Guide, Catheter, 1); MFE (Agent, Injectable, Embolic, 1).
Next steps
- See all 3 Ev3 Neurovascular clearances with predicates and recalls
- Run predicate analysis for product code MJN, Ev3 Neurovascular's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.