Clearance Summary
BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS received FDA 510(k) clearance under submission number K120823, sponsored by Fresenius Medical Care North America, Design Cente. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2012-06-15.
- Submission: K120823
- Applicant / Sponsor: Fresenius Medical Care North America, Design Cente
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2012-06-15
Classification & Regulation
This clearance is catalogued under FDA product code FJK and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.