Avenu Medical, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Avenu Medical, Inc.” (first 2018, latest 2019), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 98 days. Since 2017 the median was 98 days, against 98 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2018 | 1 | 98 |
| 2019 | 2 | 68 |
| 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 Avenu Medical, Inc. took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PQK | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access | 4 | 3 |
Review panels
- Cardiovascular (4)
Most recent Avenu Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191114 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle | PQK | 2019-08-09 | 105 |
| K183615 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle | PQK | 2019-01-25 | 30 |
| K181725 | Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) | PQK | 2018-10-05 | 98 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170004 | De Novo | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access | 2018-06-22 |
Recalls
openFDA lists no recalls under a recalling firm named Avenu Medical, Inc..
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 Avenu Medical, Inc.?
FDA lists 3 510(k) clearances under the applicant name “Avenu Medical, Inc.” (first 2018, latest 2019), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Avenu Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Avenu Medical, Inc. is 98 days. Since 2017: 98 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Avenu Medical, Inc.?
The most frequent FDA product codes under this applicant name are PQK (Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access, 4).
Next steps
- See all 3 Avenu Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PQK, Avenu 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.