Cardiosolutions, Inc.: FDA clearances and approvals
Cardiosolutions, Inc. has 5 FDA 510(k) clearances (first 2010, latest 2014), across 4 product codes in 1 review panel. Median 510(k) review time: 104 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 104 |
| 2013 | 1 | 71 |
| 2014 | 1 | 34 |
| 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 | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DRA | Catheter, Steerable | 1 | 1 |
| DYG | Catheter, Flow Directed | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Cardiosolutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140015 | CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER | DYB | 2014-02-05 | 34 |
| K131332 | CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER | DYB | 2013-07-19 | 71 |
| K120086 | CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM | DRA | 2012-04-24 | 104 |
| K094048 | PERCUPRO MESSENGER BALLOON CATHETER | DYG | 2011-07-14 | 560 |
| K094062 | PERCU-PRO GUIDEWIRE | DQX | 2010-09-27 | 270 |
Recalls
openFDA lists no recalls under a recalling firm named Cardiosolutions, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Cardiosolutions, Inc. have?
Cardiosolutions, Inc. has 5 FDA 510(k) clearances (first 2010, latest 2014), across 4 product codes in 1 review panel.
How long does FDA take to clear Cardiosolutions, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cardiosolutions, Inc.'s cleared 510(k)s is 104 days.
What devices does Cardiosolutions, Inc. make?
Its most frequent FDA product codes are DYB (Introducer, Catheter, 2); DQX (Wire, Guide, Catheter, 1); DRA (Catheter, Steerable, 1).
Has Cardiosolutions, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cardiosolutions, Inc. Related entities may recall under other names.
Next steps
- See all 5 Cardiosolutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Cardiosolutions, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.