Angeion Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Angeion Corp.” (first 1987, latest 1993), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 136 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | 3 | 3 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| GBX | Catheter, Irrigation | 1 | 1 |
| MAV | Syringe, Balloon Inflation | 1 | 1 |
| ODC | Endoscope Channel Accessory | 1 | 1 |
Review panels
- Cardiovascular (4)
- Gastroenterology and Urology (1)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Angeion Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921757 | ANGEION IGITAL ANGEFLATOR | MAV | 1993-03-18 | 339 |
| K925533 | ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET | GBX | 1993-01-12 | 71 |
| K915719 | ANGEION ENDOSCOPIC VALVE SEAL | ODC | 1992-02-18 | 60 |
| K902377 | ANGEFLATOR(TM) | DXT | 1990-12-13 | 197 |
| K895580 | Y-ADAPTER W/THOUY BORST | DYB | 1990-04-30 | 227 |
| K894446 | ANGEION HEMOSTASIS VALVE INTRODUCER | DYB | 1989-11-30 | 136 |
| K871153 | CATHETER INTRODUCER | DYB | 1987-06-24 | 92 |
Recalls
openFDA lists no recalls under a recalling firm named Angeion Corp..
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 Angeion Corp.?
FDA lists 7 510(k) clearances under the applicant name “Angeion Corp.” (first 1987, latest 1993), across 5 product codes in 4 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 Angeion Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Angeion Corp. is 136 days.
Which FDA product codes appear under Angeion Corp.?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 3); DXT (Injector And Syringe, Angiographic, 1); GBX (Catheter, Irrigation, 1).
Next steps
- See all 7 Angeion Corp. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Angeion Corp.'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.