PressureWire X— 510(k) K180558
Substantially EquivalentSt. Jude Medical (Now Part of Abbott Medical)
FDA 510(k) clearance K180558 for PressureWire X, Substantially Equivalent on 2018-03-28. Applicant: St. Jude Medical (Now Part of Abbott Medical). Device class: 2.
Clearance details
- Applicant
- St. Jude Medical (Now Part of Abbott Medical)
- Product code
- Code DXO
- Device class
- Class 2
- Regulation
- 21 CFR 870.2870
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- St. Paul, MN, US
Recent devices under product code DXO
view allAdverse events under product code DXO
product code DXO- Death
- 10
- Injury
- 156
- Malfunction
- 884
- Total
- 1,050
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.