510(k) K253146
K253146 is an FDA 510(k) premarket notification submitted by Rapid-Medical , Ltd. for the device "Hyperdrive 35 Guidewire". The FDA issued a decision of Substantially Equivalent on September 18, 2026. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Rapid-Medical , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2026
- Date Received
- September 25, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type