Clearance Summary
MODEL SP 5507 5-LUMEN THERMODILUTION CAT received FDA 510(k) clearance under submission number K811537, sponsored by Gould, 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 1981-06-18.
- Submission: K811537
- Applicant / Sponsor: Gould, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1915
- Decision date: 1981-06-18
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.