Clearance Summary
INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 received FDA 510(k) clearance under submission number K100518, sponsored by Instrumed International, 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 2010-08-31.
- Submission: K100518
- Applicant / Sponsor: Instrumed International, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4475
- Decision date: 2010-08-31
Classification & Regulation
This clearance is catalogued under FDA product code DWP and 21 CFR 870.4475, within the Cardiovascular review panel as a Class II device.