Concentric Medical, Inc.: FDA filings under this applicant name
FDA lists 45 510(k) clearances under the applicant name “Concentric Medical, Inc.” (first 2001, latest 2018), plus 1 De Novo decision, across 7 product codes in 2 review panels. Median 510(k) review time under this name: 99 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 Stryker, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 126 |
| 2013 | 2 | 138 |
| 2014 | 3 | 131 |
| 2015 | 2 | 128 |
| 2016 | 1 | 30 |
| 2017 | 0 | — |
| 2018 | 1 | 113 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Concentric Medical, Inc. took a median 113 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 19 | 19 |
| NRY | Catheter, Thrombus Retriever | 16 | 16 |
| DQO | Catheter, Intravascular, Diagnostic | 6 | 6 |
| POL | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | 2 | 1 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| KRD | Device, Vascular, For Promoting Embolization | 1 | 1 |
| QEZ | Aspiration Thrombectomy Catheter | 1 | 1 |
Review panels
- Cardiovascular (28)
- Neurology (18)
Most recent Concentric Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173352 | Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) | POL | 2018-02-15 | 113 |
| K153729 | 8F FlowGate2 Balloon Guide Catheter | DQY | 2016-01-27 | 30 |
| K150616 | Trevo XP ProVue Retriever (4x30mm) | NRY | 2015-06-12 | 94 |
| K143077 | Trevo XP ProVue Retriever (6X25mm) | NRY | 2015-04-06 | 161 |
| K133177 | MODIFIED HD GUIDE CATHETER | DQY | 2014-02-25 | 131 |
| K133464 | MODIFIED TREVO PROVUE RETRIEVER | NRY | 2014-01-17 | 66 |
| K132641 | MODIFIED TREVO PROVUE RETRIEVER | NRY | 2014-01-13 | 140 |
| K131437 | MODIFIED CONCENTRIC MICROCATHETER | DQO | 2013-10-11 | 144 |
| K131492 | MODIFIED FLOWGATE BALLOON GUIDE CATHETER | DQY | 2013-10-03 | 133 |
| K122581 | MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 | DQY | 2012-11-21 | 90 |
35 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150049 | De Novo | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | 2016-09-02 |
Recalls
8 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2015-08-19.
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 Concentric Medical, Inc.?
FDA lists 45 510(k) clearances under the applicant name “Concentric Medical, Inc.” (first 2001, latest 2018), plus 1 De Novo decision, across 7 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 Concentric Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Concentric Medical, Inc. is 99 days.
Which FDA product codes appear under Concentric Medical, Inc.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 19); NRY (Catheter, Thrombus Retriever, 16); DQO (Catheter, Intravascular, Diagnostic, 6).
Next steps
- See all 45 Concentric Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQY, Concentric Medical, Inc.'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.