Clearance Summary
EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE received FDA 510(k) clearance under submission number K063293, sponsored by Edwards Lifesciences Services GmbH. 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 2007-03-23.
- Submission: K063293
- Applicant / Sponsor: Edwards Lifesciences Services GmbH
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2007-03-23
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.