Clearance Summary
MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE) received FDA 510(k) clearance under submission number K003483, sponsored by Lake Region Mfg., 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 2000-12-06.
- Submission: K003483
- Applicant / Sponsor: Lake Region Mfg., Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2000-12-06
Classification & Regulation
This clearance is catalogued under FDA product code DQX and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.