Micrus Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Micrus Corp.” (first 2001, latest 2004), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 74 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 | 5 | 5 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
Review panels
- Neurology (5)
- Cardiovascular (1)
Most recent Micrus Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033813 | MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE | HCG | 2004-02-04 | 57 |
| K032872 | MICRUS MICROCOIL SYSTEM | HCG | 2003-11-28 | 74 |
| K032624 | MICRUS MICROCATHETER | DQO | 2003-09-10 | 15 |
| K031578 | MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR | HCG | 2003-08-01 | 73 |
| K022420 | MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01 | HCG | 2002-10-22 | 90 |
| K002056 | MICRUS MICROCOIL DELIVERY SYSTEM, MDS03 | HCG | 2001-01-11 | 189 |
Recalls
openFDA lists no recalls under a recalling firm named Micrus Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Micrus Endovascular Corporation (23 510(k)s)
- Micrus Design Technology, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Micrus Corp.?
FDA lists 6 510(k) clearances under the applicant name “Micrus Corp.” (first 2001, latest 2004), across 2 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 Micrus Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micrus Corp. is 74 days.
Which FDA product codes appear under Micrus Corp.?
The most frequent FDA product codes under this applicant name are HCG (Device, Neurovascular Embolization, 5); DQO (Catheter, Intravascular, Diagnostic, 1).
Next steps
- See all 6 Micrus Corp. clearances with predicates and recalls
- Run predicate analysis for product code HCG, Micrus Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.