SLIM Microcatheter— 510(k) K260199
Substantially EquivalentBalt USA, LLC
FDA 510(k) clearance K260199 for SLIM Microcatheter, Substantially Equivalent on 2026-07-13. Applicant: Balt USA, LLC. Device class: 2.
Summary
Balt USA's SLIM Microcatheter is filed under QJP, neurovasculature percutaneous catheters. The record doesn't give lengths or diameters.
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 172 calendar days after FDA received it (January 22 to July 13, 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.