Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection— 510(k) K181529
Substantially EquivalentContego Medical, LLC
FDA 510(k) clearance K181529 for Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection, Substantially Equivalent on 2018-12-06. Applicant: Contego Medical, LLC.
Clearance details
- Applicant
- Contego Medical, LLC
- Product code
- Code LIT
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raleigh, NC, US
Adverse events under product code LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
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.