K232852 is an FDA 510(k) clearance for the Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable. This device is classified as a Catheter, Septostomy (Class II - Special Controls, product code DXF).
Submitted by Cross Vascular, Inc. (Solana Beach, US). The FDA issued a Cleared decision on October 12, 2023, 28 days after receiving the submission on September 14, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5175.
| 510(k) Number | K232852 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2023 |
| Decision Date | October 12, 2023 |
| Days to Decision | 28 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 |