FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9— 510(k) K010268
Substantially EquivalentFresenius Medical Care North America
FDA 510(k) clearance K010268 for FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9, Substantially Equivalent on 2001-04-27. Applicant: Fresenius Medical Care North America.
Clearance details
- Applicant
- Fresenius Medical Care North America
- Product code
- Code KOC
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, 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.