BosCATH Support Catheter— 510(k) K254046
Substantially EquivalentSonorous NV, Inc.
FDA 510(k) clearance K254046 for BosCATH Support Catheter, Substantially Equivalent on 2026-04-21. Applicant: Sonorous NV, Inc.. Device class: 2.
Summary
Sonorous NV's BosCATH Support Catheter is filed under product code QJP (Catheter, Percutaneous, Neurovasculature).
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Sonorous NV filed from Lake Forest, California. The decision came 125 calendar days after FDA received it (December 17, 2025 to April 21, 2026).
Clearance details
- Applicant
- Sonorous NV, Inc.
- Product code
- Product code QJP
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Forest, CA, US
Recent devices under product code QJP
view allAdverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.