Clearance Summary
CATHETER, MEDIASTINAL&PERICARDIAL received FDA 510(k) clearance under submission number K771986, sponsored by The Minnesota Back Brace Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1977-10-28.
- Submission: K771986
- Applicant / Sponsor: The Minnesota Back Brace Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4370
- Decision date: 1977-10-28
Classification & Regulation
This clearance is catalogued under FDA product code FHF and 21 CFR 876.4370, within the Gastroenterology, Urology review panel as a Class II device.