Intervalve, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Intervalve, Inc.” (first 2013, latest 2015), across 1 product code in 1 review panel. Median 510(k) review time under this name: 80 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 |
|---|---|---|
| 2013 | 2 | 100 |
| 2014 | 1 | 78 |
| 2015 | 2 | 94 |
| 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 |
|---|---|---|---|
| OZT | Balloon Aortic Valvuloplasty | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Intervalve, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152150 | V8 Balloon Aortic Valvuloplasty Catheter | OZT | 2015-12-18 | 137 |
| K150343 | V8 Transluminal BAV Catheter | OZT | 2015-04-03 | 51 |
| K133607 | V8 TRANSLUMINAL BAV CATHETER | OZT | 2014-02-11 | 78 |
| K132728 | V8 TRANSLUMINAL BAV CATHETER | OZT | 2013-11-22 | 80 |
| K123111 | V8 TRANSLUMINAL BAV CATHETER | OZT | 2013-01-31 | 120 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-03-14.
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.
Device clinical trials
An industry sponsor named Intervalve, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02472106: Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure (Completed, started 2015-06)
- NCT02099942: Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device (Completed, started 2014-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intervalve, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Intervalve, Inc.” (first 2013, latest 2015), 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 Intervalve, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intervalve, Inc. is 80 days.
Which FDA product codes appear under Intervalve, Inc.?
The most frequent FDA product codes under this applicant name are OZT (Balloon Aortic Valvuloplasty, 5).
Next steps
- See all 5 Intervalve, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OZT, Intervalve, 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.