Power Acute Triple Lumen Hemodialysis Catheter— 510(k) K222170
Substantially EquivalentHealth Line International Corporation
FDA 510(k) clearance K222170 for Power Acute Triple Lumen Hemodialysis Catheter, Substantially Equivalent on 2023-01-13. Applicant: Health Line International Corporation.
Clearance details
- Applicant
- Health Line International Corporation
- Product code
- Code NIE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Slat Lake City, UT, US
Adverse events under product code NIE
product code NIE- Death
- 9
- Other
- 1
- Total
- 10
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.