Clearance Summary
PT HEPARIN ADSORBENT received FDA 510(k) clearance under submission number K870771, sponsored by Probe-Tek, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1987-04-23.
- Submission: K870771
- Applicant / Sponsor: Probe-Tek, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 1987-04-23
Classification & Regulation
This clearance is catalogued under FDA product code JPA and 21 CFR 864.5425, within the Hematology review panel as a Class II device.