Micrus Endovascular Corporation: FDA clearances and approvals
Micrus Endovascular Corporation has 23 FDA 510(k) clearances (first 2005, latest 2011), across 4 product codes in 2 review panels. Median 510(k) review time: 40 days. openFDA lists 1 product recall by a recalling firm named Micrus Endovascular Corporation.
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 |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | 11 | 11 |
| DQO | Catheter, Intravascular, Diagnostic | 6 | 6 |
| DQX | Wire, Guide, Catheter | 3 | 3 |
| MJN | Catheter, Intravascular Occluding, Temporary | 3 | 3 |
Review panels
- Cardiovascular (12)
- Neurology (11)
Most recent Micrus Endovascular Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103780 | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO | MJN | 2011-01-26 | 30 |
| K102818 | MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE | DQX | 2010-12-03 | 66 |
| K092702 | MICRUS MICROCATHETER, MODEL COURIER 270 | DQO | 2009-11-20 | 79 |
| K091504 | MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00 | MJN | 2009-06-19 | 29 |
| K083922 | MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 | DQO | 2009-05-06 | 126 |
| K090274 | MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE | DQX | 2009-03-03 | 27 |
| K083646 | MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL | HCG | 2009-01-02 | 24 |
| K082739 | MICRUS MICROCOIL DELIVERY SYSTEM | HCG | 2008-10-17 | 29 |
| K080861 | MICRUS ASCENT OCCLUSION BALLOON CATHETER | MJN | 2008-08-27 | 153 |
| K080379 | MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT | HCG | 2008-06-30 | 138 |
13 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2006-09-08.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Micrus Endovascular Corporation have?
Micrus Endovascular Corporation has 23 FDA 510(k) clearances (first 2005, latest 2011), across 4 product codes in 2 review panels.
How long does FDA take to clear Micrus Endovascular Corporation's 510(k)s?
The median time from FDA receipt to decision across Micrus Endovascular Corporation's cleared 510(k)s is 40 days.
What devices does Micrus Endovascular Corporation make?
Its most frequent FDA product codes are HCG (Device, Neurovascular Embolization, 11); DQO (Catheter, Intravascular, Diagnostic, 6); DQX (Wire, Guide, Catheter, 3).
Has Micrus Endovascular Corporation had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Micrus Endovascular Corporation; the most recent began 2006-09-08. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 23 Micrus Endovascular Corporation clearances with predicates and recalls
- Run predicate analysis for product code HCG, Micrus Endovascular Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.