510(k) clearance
Hyperdrive 35 Guidewire
- 510(k) number
- K253146
- Applicant
- Rapid-Medical , Ltd.
- Decision date
- Sep 18, 2026
- Date received
- Sep 25, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- DQX
- Device type
- Wire, Guide, Catheter
- Device class
- Class II
- Regulation
- 21 CFR 870.1330
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- Y
- Location
- Yokneam, IL