Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete— 510(k) K163200
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K163200 for Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete, Substantially Equivalent on 2016-12-14. Applicant: Boston Scientific Corporation.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code LOX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Maple Grove, MN, US
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.