CAREline Airless Hemodialysis Blood Tubing Sets— 510(k) K172238
Substantially EquivalentFresenius Medical Care Renal Therapies Group, LLC
FDA 510(k) clearance K172238 for CAREline Airless Hemodialysis Blood Tubing Sets, Substantially Equivalent on 2017-12-14. Applicant: Fresenius Medical Care Renal Therapies Group, LLC.
Clearance details
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- Product code
- Code KOC
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Adverse events under product code KOC
product code KOC- Death
- 4
- Total
- 4
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.