Clearance Summary
PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR received FDA 510(k) clearance under submission number K991886, sponsored by Pulsion Medical Systems, 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 2000-05-11.
- Submission: K991886
- Applicant / Sponsor: Pulsion Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1915
- Decision date: 2000-05-11
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.