K241042 is an FDA 510(k) clearance for the SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198). This device is classified as a Trocar (Class II - Special Controls, product code DRC).
Submitted by Pressure Products Medical Device Manufacturing, LLC (Morton, US). The FDA issued a Cleared decision on May 17, 2024, 30 days after receiving the submission on April 17, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1390.
| 510(k) Number | K241042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2024 |
| Decision Date | May 17, 2024 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRC — Trocar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1390 |