Clearance Summary
ILT SUPPORT CATHETER .014, MODEL C114LW1; ILT SUPPORT CATHETER ADVANCING MECHANISM, MODEL A11AM1 received FDA 510(k) clearance under submission number K012169, sponsored by Intra Luminal Therapeutics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-08-30.
- Submission: K012169
- Applicant / Sponsor: Intra Luminal Therapeutics, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2001-08-30
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.