Clearance Summary
CATHTONG II PICC Catheter received FDA 510(k) clearance under submission number K232594, sponsored by L&Z Us, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2023-09-22.
- Submission: K232594
- Applicant / Sponsor: L&Z Us, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5970
- Decision date: 2023-09-22
Classification & Regulation
This clearance is catalogued under FDA product code LJS and 21 CFR 880.5970, within the General Hospital review panel as a Class II device.