Clearance Summary
JOBST ATHROMBIC PUMP SYSTEM 2600 received FDA 510(k) clearance under submission number K980456, sponsored by Jobst A Beiersdorf Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-05-05.
- Submission: K980456
- Applicant / Sponsor: Jobst A Beiersdorf Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 1998-05-05
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.