Clearance Summary
SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter received FDA 510(k) clearance under submission number K241115, sponsored by Spectrum Vascular. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2024-11-27.
- Submission: K241115
- Applicant / Sponsor: Spectrum Vascular
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2024-11-27
Classification & Regulation
This clearance is catalogued under FDA product code FOZ and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.