Clearance Summary
PERCUTANEOUS INTRODUCER KIT received FDA 510(k) clearance under submission number K831636, sponsored by Accu-Line. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1983-08-24.
- Submission: K831636
- Applicant / Sponsor: Accu-Line
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 1983-08-24
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.