Angioscore, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Angioscore, Inc.” (first 2005, latest 2015), across 1 product code in 1 review panel. Median 510(k) review time under this name: 47 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 | 1 | 133 |
| 2014 | 1 | 113 |
| 2015 | 1 | 139 |
| 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 |
|---|---|---|---|
| PNO | Catheter, Percutaneous, Cutting/Scoring | 13 | 13 |
Review panels
- Cardiovascular (13)
Most recent Angioscore, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142983 | AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating | PNO | 2015-03-04 | 139 |
| K133998 | ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING | PNO | 2014-04-18 | 113 |
| K122685 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | PNO | 2013-01-11 | 133 |
| K112182 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | PNO | 2011-08-26 | 29 |
| K110767 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | PNO | 2011-04-15 | 28 |
| K101735 | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY | PNO | 2010-07-14 | 23 |
| K100303 | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY | PNO | 2010-03-22 | 47 |
| K091966 | ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 | PNO | 2009-07-30 | 29 |
| K082059 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | PNO | 2008-08-11 | 21 |
| K081220 | MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER | PNO | 2008-05-28 | 28 |
3 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2010-11-16.
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 Angioscore, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00686647: AngioSculpt® Coronary Bifurcation Study (Completed, started 2008-04)
Frequently asked questions
How many FDA 510(k) clearances are listed under Angioscore, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Angioscore, Inc.” (first 2005, 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 Angioscore, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Angioscore, Inc. is 47 days.
Which FDA product codes appear under Angioscore, Inc.?
The most frequent FDA product codes under this applicant name are PNO (Catheter, Percutaneous, Cutting/Scoring, 13).
Next steps
- See all 13 Angioscore, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PNO, Angioscore, 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.