510(k) K240900
K240900 is an FDA 510(k) premarket notification submitted by Atraverse Medical for the device "HOTWIRE RF Guidewire". The FDA issued a decision of Substantially Equivalent on May 1, 2024. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175. Atraverse Medical has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 2024
- Date Received
- April 1, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Septostomy
- Device Class
- Class II
- Regulation Number
- 870.5175
- Review Panel
- CV
- Submission Type