Clearance Summary
THORACIC CATHETER WITH GUIDE received FDA 510(k) clearance under submission number K913542, sponsored by Intl. Medical Devices , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1992-01-21.
- Submission: K913542
- Applicant / Sponsor: Intl. Medical Devices , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1992-01-21
Classification & Regulation
This clearance is catalogued under FDA product code GBX and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.