510(k) K242076
K242076 is an FDA 510(k) premarket notification submitted by Baylis Medical Company for the device "VersaCross RF Wire". The FDA issued a decision of Substantially Equivalent on November 1, 2024. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2024
- Date Received
- July 16, 2024
- Clearance Type
- Special
- 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