Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender— 510(k) K180485
UnknownCovidien, LLC
FDA 510(k) clearance K180485 for Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender, Unknown on 2018-07-27. Applicant: Covidien, LLC.
Clearance details
- Applicant
- Covidien, LLC
- Product code
- Code FJS
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Adverse events under product code FJS
product code FJS- Death
- 34
- Injury
- 652
- Malfunction
- 576
- Other
- 6
- Total
- 1,268
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.