Clearance Summary
4F STERILE BALLOON-LESS, CATHETER 913-28 received FDA 510(k) clearance under submission number K791026, sponsored by Waters Assoc., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1979-06-22.
- Submission: K791026
- Applicant / Sponsor: Waters Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1915
- Decision date: 1979-06-22
Classification & Regulation
This clearance is catalogued under FDA product code KRB and 21 CFR 870.1915, within the Cardiovascular review panel as a Class II device.