K241145
- 510(k) number
- K241145
- Device name
- TLAB® Transvenous Liver Biopsy System (TF-18C)
- Applicant
- Argon Medical Devices, Inc. TX · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2024-08-01
- Date received
- 2024-04-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K241145.pdf
Official FDA record: K241145
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.