Clearance Summary
SCANLAN TUNNELER, SHEATH & TIP received FDA 510(k) clearance under submission number K851825, sponsored by Scanlan Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-07-12.
- Submission: K851825
- Applicant / Sponsor: Scanlan Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4500
- Decision date: 1985-07-12
Classification & Regulation
This clearance is catalogued under FDA product code DWS and 21 CFR 870.4500, within the Cardiovascular review panel as a Class I device.