LIA-1 Catheter (542-1)— 510(k) K251402
Substantially EquivalentLeadoptik, Inc.
FDA 510(k) clearance K251402 for LIA-1 Catheter (542-1), Substantially Equivalent on 2025-12-19. Applicant: Leadoptik, Inc.. Device class: 2.
Clearance details
- Applicant
- Leadoptik, Inc.
- Product code
- Code KTI
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
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More clearances from Leadoptik, Inc.
view allAdverse events under product code KTI
product code KTI- Malfunction
- 642
- Total
- 642
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.