Clearance Summary
6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET received FDA 510(k) clearance under submission number K131687, sponsored by Medical Components, Inc.. 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 2013-08-16.
- Submission: K131687
- Applicant / Sponsor: Medical Components, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5970
- Decision date: 2013-08-16
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.