Next Generation 088 Catheter— 510(k) K254223
Substantially EquivalentBalt USA, LLC
FDA 510(k) clearance K254223 for Next Generation 088 Catheter, Substantially Equivalent on 2026-04-16. Applicant: Balt USA, LLC. Device class: 2.
Summary
Balt USA's Next Generation 088 Catheter is filed under product code QJP (Catheter, Percutaneous, Neurovasculature). The record doesn't describe the catheter beyond its name and that code name.
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.
Balt USA filed from Irvine, California. The decision came 108 calendar days after FDA received it (December 29, 2025 to April 16, 2026).
Clearance details
- Applicant
- Balt USA, LLC
- 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
- Irvine, CA, US
Recent devices under product code QJP
view allMore clearances from Balt USA, LLC
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.