Clearance Summary
POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D received FDA 510(k) clearance under submission number K003452, sponsored by Ep Technologies, 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 2000-12-07.
- Submission: K003452
- Applicant / Sponsor: Ep Technologies, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1220
- Decision date: 2000-12-07
Classification & Regulation
This clearance is catalogued under FDA product code DRF and 21 CFR 870.1220, within the Cardiovascular review panel as a Class II device.