SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON— 510(k) K103095
Substantially EquivalentMedtronic, Ireland
FDA 510(k) clearance K103095 for SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON, Substantially Equivalent on 2010-10-22. Applicant: Medtronic, Ireland. Device class: 2.
Clearance details
- Applicant
- Medtronic, Ireland
- Product code
- Code LOX
- Device class
- Class 2
- Regulation
- 21 CFR 870.5100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Rosa, CA, US
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Adverse events under product code LOX
product code LOX- Death
- 190
- Injury
- 1,498
- Malfunction
- 9,670
- Total
- 11,358
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.