K241414 is an FDA 510(k) clearance for the CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C). 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 September 26, 2024, 132 days after receiving the submission on May 17, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5175.
| 510(k) Number | K241414 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2024 |
| Decision Date | September 26, 2024 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXF - Catheter, Septostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5175 |