Clearance Summary
PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 received FDA 510(k) clearance under submission number K020587, sponsored by Pulsion Medical Systems AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-05-23.
- Submission: K020587
- Applicant / Sponsor: Pulsion Medical Systems AG
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1915
- Decision date: 2002-05-23
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.