Arstasis, Inc.: FDA clearances and approvals
Arstasis, Inc. has 14 FDA 510(k) clearances (first 2010, latest 2015), across 2 product codes in 1 review panel. Median 510(k) review time: 62 days. openFDA lists 1 product recall by a recalling firm named Arstasis, Inc. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 29 |
| 2013 | 3 | 115 |
| 2014 | 3 | 63 |
| 2015 | 1 | 29 |
| 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | 12 | 12 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 2 | 2 |
Review panels
- Cardiovascular (14)
Most recent Arstasis, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151877 | MicroTract Access System | DRE | 2015-08-07 | 29 |
| K140871 | AXERA 2 ACCESS SYSTEM | DYB | 2014-06-06 | 63 |
| K140287 | AXERA RX ACCESS SYSTEM | DYB | 2014-05-16 | 100 |
| K140201 | AXERA 2 ACCESS SYSTEM | DYB | 2014-03-28 | 60 |
| K132263 | AXERA 2 ACCESS SYSTEM | DYB | 2013-08-19 | 28 |
| K123618 | AXERA 2 ACCESS SYSTEM | DYB | 2013-03-24 | 121 |
| K123135 | AXERA 2 ACCESS SYSTEM MODEL AXE200 | DYB | 2013-01-28 | 115 |
| K121521 | AXERA ACCESS SYSTEM | DYB | 2012-06-21 | 29 |
| K113110 | AXERA ACCESS SYSTEM | DYB | 2011-11-09 | 20 |
| K103421 | ARSTASIS DILATOR ADAPTER | DRE | 2011-05-24 | 183 |
4 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: 2010-10-19.
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.
Device clinical trials
Arstasis, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01271946: A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System (Completed, started 2010-11)
Frequently asked questions
How many FDA 510(k) clearances does Arstasis, Inc. have?
Arstasis, Inc. has 14 FDA 510(k) clearances (first 2010, latest 2015), across 2 product codes in 1 review panel.
How long does FDA take to clear Arstasis, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Arstasis, Inc.'s cleared 510(k)s is 62 days.
What devices does Arstasis, Inc. make?
Its most frequent FDA product codes are DYB (Introducer, Catheter, 12); DRE (Dilator, Vessel, For Percutaneous Catheterization, 2).
Has Arstasis, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Arstasis, Inc; the most recent began 2010-10-19. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 14 Arstasis, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Arstasis, 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.