Infinity Angioplasty Balloon Catheter— 510(k) K192399
Substantially EquivalentInfinity Angioplasty Balloon Company, LLC
FDA 510(k) clearance K192399 for Infinity Angioplasty Balloon Catheter, Substantially Equivalent on 2020-05-20. Applicant: Infinity Angioplasty Balloon Company, LLC.
Clearance details
- Applicant
- Infinity Angioplasty Balloon Company, LLC
- Product code
- Code LIT
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Toledo, OH, 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.