Alsius Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Alsius Corp.” (first 2003, latest 2008), across 1 product code in 1 review panel. Median 510(k) review time under this name: 41 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 |
|---|---|---|---|
| NCX | System, Hypothermia, Intravenous, Cooling | 9 | 9 |
Review panels
- Neurology (9)
Most recent Alsius Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081936 | SOLEX CATHETER, MODEL SL2593 | NCX | 2008-08-13 | 37 |
| K072234 | THERMOGARD XP THERMAL REGULATION SYSTEM | NCX | 2007-08-23 | 13 |
| K070161 | QUATTRO CATHETER MODEL IC4593 | NCX | 2007-02-15 | 29 |
| K063829 | THERMOGARD THERMAL REGULATION SYSTEM | NCX | 2007-01-22 | 27 |
| K060308 | COOLGARD 3000 | NCX | 2006-04-26 | 78 |
| K052443 | ICY CATHETER, MODEL IC-3893A | NCX | 2005-10-17 | 41 |
| K051912 | COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B | NCX | 2005-10-11 | 89 |
| K030421 | ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM | NCX | 2003-10-23 | 255 |
| K014241 | COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D | NCX | 2003-08-01 | 583 |
Recalls
6 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2007-01-01.
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 Alsius Corp.?
FDA lists 9 510(k) clearances under the applicant name “Alsius Corp.” (first 2003, latest 2008), 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 Alsius Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alsius Corp. is 41 days.
Which FDA product codes appear under Alsius Corp.?
The most frequent FDA product codes under this applicant name are NCX (System, Hypothermia, Intravenous, Cooling, 9).
Next steps
- See all 9 Alsius Corp. clearances with predicates and recalls
- Run predicate analysis for product code NCX, Alsius 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.