K203459 is an FDA 510(k) clearance for the SafeCross Transseptal Puncture and Introducer (TSP/I) System. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by East End Medical I, LLC (Sunrise, US). The FDA issued a Cleared decision on July 6, 2021, 224 days after receiving the submission on November 24, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K203459 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2020 |
| Decision Date | July 06, 2021 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB - Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |