Clearance Summary
MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY received FDA 510(k) clearance under submission number K861710, sponsored by Johnson & Johnson Professionals, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1986-07-09.
- Submission: K861710
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2330
- Decision date: 1986-07-09
Classification & Regulation
This clearance is catalogued under FDA product code DXK and 21 CFR 870.2330, within the Cardiovascular review panel as a Class II device.