Clearance Summary
Disposable High-pressure Extension Lines received FDA 510(k) clearance under submission number K230668, sponsored by Precision Medical Plastics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-06-14.
- Submission: K230668
- Applicant / Sponsor: Precision Medical Plastics , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 2024-06-14
Classification & Regulation
This clearance is catalogued under FDA product code DXT and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.