K241910 is an FDA 510(k) clearance for the Neonav ECG Tip Location System. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Navi Medical Technologies (Carlton, AU). The FDA issued a Cleared decision on January 19, 2025, 202 days after receiving the submission on July 1, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K241910 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2024 |
| Decision Date | January 19, 2025 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LJS - Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |