510(k) · Cleared
ClearedBresagen Catheter, Model CS-3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bresagen, Inc. · HCA Catheter, Ventricular
Cleared on Aug 6, 2002 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 6, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- HCA
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HCA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All HCA devicesHCA Catheter, Ventricular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCA
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · HCA
Too few HCA 510(k)s in any year since 2007 to give a median.
Recalls per year · HCA
No recall names HCA since 2007.
Adverse event reports per year · HCA
1in 2021
MAUDE reports naming product code HCA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 8 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For injection of material into, or removal of material from, the brain during intracranial procedures. This device is not intended for implant. This device is ET0 sterilized and intended for one time use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021481: Bresagen Catheter, Model CS-3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021481
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026