Clearance Summary
THORACIC CATHETER STYLET received FDA 510(k) clearance under submission number K913543, sponsored by Intl. Medical Devices , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1991-10-04.
- Submission: K913543
- Applicant / Sponsor: Intl. Medical Devices , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1380
- Decision date: 1991-10-04
Classification & Regulation
This clearance is catalogued under FDA product code DRB and 21 CFR 870.1380, within the Cardiovascular review panel as a Class II device.