510(k) K253667
K253667 is an FDA 510(k) premarket notification submitted by Sp Medical A/S for the device "Accoat Guide Wire". The FDA issued a decision of Substantially Equivalent on July 14, 2026. 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
- July 14, 2026
- Date Received
- November 21, 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