510(k) K250203
K250203 is an FDA 510(k) premarket notification submitted by Sureax Medical, LLC for the device "SureAx-Guide". The FDA issued a decision of Substantially Equivalent on October 17, 2025. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2025
- Date Received
- January 24, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type