VersaCross™ RF Wire
FDA 510(k) clearance K242076 · decided 2024-11-01
Clearance details
- K-number
- K242076
- Device name
- VersaCross™ RF Wire
- Applicant
- Baylis Medical Company
- Decision
- Substantially Equivalent
- Date received
- 2024-07-16
- Decision date
- 2024-11-01
- Days to decision
- 108 days
- Clearance type
- Special
- Product code
- DXF
- Device class
- 2
- Regulation number
- 870.5175
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mississauga, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.