Clearance Summary
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS received FDA 510(k) clearance under submission number K000956, sponsored by Boston Scientific Scimed, 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 2000-04-21.
- Submission: K000956
- Applicant / Sponsor: Boston Scientific Scimed, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2000-04-21
Classification & Regulation
This clearance is catalogued under FDA product code DQO and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.