Clearance Summary
BALLOON RETENTION CHEST CATHETER received FDA 510(k) clearance under submission number K802025, sponsored by Loseff Medical Designers, 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 1980-09-26.
- Submission: K802025
- Applicant / Sponsor: Loseff Medical Designers, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1980-09-26
Classification & Regulation
This clearance is catalogued under FDA product code GBA and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.