Aptus Endosystems, Inc.: FDA clearances and approvals
Aptus Endosystems, Inc. has 4 FDA 510(k) clearances (first 2012, latest 2014), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 30 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 113 |
| 2013 | 1 | 30 |
| 2014 | 2 | 26 |
| 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 |
|---|---|---|---|
| OTD | Endovascular Suturing System | 5 | 4 |
Review panels
- Cardiovascular (5)
Most recent Aptus Endosystems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141041 | APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE | OTD | 2014-05-16 | 23 |
| K140036 | APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH | OTD | 2014-02-06 | 30 |
| K130677 | APTUS HELI-FX AORTIC SECUREMENT SYSTEM | OTD | 2013-04-12 | 30 |
| K121168 | APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH | OTD | 2012-08-08 | 113 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN100026 | De Novo | Endovascular Suturing System | 2011-11-21 |
Recalls
openFDA lists no recalls under a recalling firm named Aptus Endosystems, Inc..
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 Aptus Endosystems, Inc. have?
Aptus Endosystems, Inc. has 4 FDA 510(k) clearances (first 2012, latest 2014), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Aptus Endosystems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Aptus Endosystems, Inc.'s cleared 510(k)s is 30 days.
What devices does Aptus Endosystems, Inc. make?
Its most frequent FDA product codes are OTD (Endovascular Suturing System, 5).
Has Aptus Endosystems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Aptus Endosystems, Inc. Related entities may recall under other names.
Next steps
- See all 4 Aptus Endosystems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OTD, Aptus Endosystems, Inc.'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.