Clearance Summary
ATRIUMS PDR THORACIC CATHETER received FDA 510(k) clearance under submission number K912645, sponsored by Atrium Medical Corp.. 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 1991-09-13.
- Submission: K912645
- Applicant / Sponsor: Atrium Medical Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1991-09-13
Classification & Regulation
This clearance is catalogued under FDA product code GBS and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.