Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter— 510(k) K202049
Substantially EquivalentApplied Medical Resources Corporation
FDA 510(k) clearance K202049 for Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter, Substantially Equivalent on 2021-09-07. Applicant: Applied Medical Resources Corporation.
Clearance details
- Applicant
- Applied Medical Resources Corporation
- Product code
- Code DXE
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rancho Santa, CA, US
Adverse events under product code DXE
product code DXE- Death
- 27
- Injury
- 258
- Malfunction
- 2,266
- Total
- 2,551
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.