BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS— 510(k) K120823
Substantially EquivalentFresenius Medical Care North America, Design Cente
FDA 510(k) clearance K120823 for BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS, Substantially Equivalent on 2012-06-15. Applicant: Fresenius Medical Care North America, Design Cente.
Clearance details
- Applicant
- Fresenius Medical Care North America, Design Cente
- Product code
- Code FJK
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Adverse events under product code FJK
product code FJK- Death
- 52
- Malfunction
- 3,430
- Total
- 3,482
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.