Clearance Summary
LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension received FDA 510(k) clearance under submission number K220691, sponsored by Seigla Medical, 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 2022-05-05.
- Submission: K220691
- Applicant / Sponsor: Seigla Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2022-05-05
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.