Clearance Summary
GESCO PER-Q-CATH CATHETER INTRODUCER received FDA 510(k) clearance under submission number K915167, sponsored by Gesco Intl., 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 1992-01-27.
- Submission: K915167
- Applicant / Sponsor: Gesco Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 1992-01-27
Classification & Regulation
This clearance is catalogued under FDA product code DYB and 21 CFR 870.1340, within the Cardiovascular review panel as a Class II device.