510(k) K241414
K241414 is an FDA 510(k) premarket notification submitted by Circa Scientific, Inc. for the device "CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)". The FDA issued a decision of Substantially Equivalent on September 26, 2024. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175. Circa Scientific, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2024
- Date Received
- May 17, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Septostomy
- Device Class
- Class II
- Regulation Number
- 870.5175
- Review Panel
- CV
- Submission Type