Clearance Summary
MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE received FDA 510(k) clearance under submission number K872230, sponsored by Intermedics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1987-09-15.
- Submission: K872230
- Applicant / Sponsor: Intermedics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5330
- Decision date: 1987-09-15
Classification & Regulation
This clearance is catalogued under FDA product code DBT and 21 CFR 866.5330, within the Immunology review panel as a Class I device.