K251007 is an FDA 510(k) clearance for the CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F). This device is classified as a Catheter, Septostomy (Class II - Special Controls, product code DXF).
Submitted by Circa Scientific, Inc. (Englewood, US). The FDA issued a Cleared decision on May 1, 2025, 30 days after receiving the submission on April 1, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5175.
| 510(k) Number | K251007 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2025 |
| Decision Date | May 01, 2025 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXF - Catheter, Septostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5175 |