Angiomedics, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Angiomedics, Inc.” (first 1984, latest 1987), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 89 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 3 | 3 |
| DYB | Introducer, Catheter | 2 | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 | 1 |
Review panels
- Cardiovascular (7)
- General Hospital (1)
Most recent Angiomedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873195 | SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO | DYB | 1987-12-15 | 123 |
| K872542 | SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER | LIT | 1987-09-14 | 77 |
| K872472 | SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE | DXT | 1987-09-14 | 83 |
| K863342 | SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER | DWF | 1987-03-03 | 187 |
| K861238 | ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV | DYB | 1986-07-16 | 105 |
| K852872 | ANGIOMEDICS SOFTIP CATHETER | DQO | 1985-10-11 | 95 |
| K850271 | ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR | DQO | 1985-04-03 | 70 |
| K834275 | SOFTIP CATHETER | DQO | 1984-02-04 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named Angiomedics, 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 Angiomedics, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Angiomedics, Inc.” (first 1984, latest 1987), across 5 product codes in 2 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 Angiomedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Angiomedics, Inc. is 89 days.
Which FDA product codes appear under Angiomedics, Inc.?
The most frequent FDA product codes under this applicant name are DQO (Catheter, Intravascular, Diagnostic, 3); DYB (Introducer, Catheter, 2); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 1).
Next steps
- See all 8 Angiomedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQO, Angiomedics, 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.