VersaCross RF Wire— 510(k) K242076
Substantially EquivalentBaylis Medical Company
FDA 510(k) clearance K242076 for VersaCross RF Wire, Substantially Equivalent on 2024-11-01. Applicant: Baylis Medical Company.
Clearance details
- Applicant
- Baylis Medical Company
- Product code
- Code DXF
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mississauga, CA
Adverse events under product code DXF
product code DXF- Death
- 78
- Injury
- 1,126
- Malfunction
- 507
- Other
- 1
- Total
- 1,712
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.