K241145 is an FDA 510(k) clearance for the TLAB® Transvenous Liver Biopsy System (TF-18C). This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on August 1, 2024, 98 days after receiving the submission on April 25, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K241145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2024 |
| Decision Date | August 01, 2024 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | DYB — Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |