Clearance Summary
Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC received FDA 510(k) clearance under submission number K152409, sponsored by Navilyst Medical, 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 2015-09-24.
- Submission: K152409
- Applicant / Sponsor: Navilyst Medical, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5970
- Decision date: 2015-09-24
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.