Clearance Summary
TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENT received FDA 510(k) clearance under submission number K945319, sponsored by Tetra Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1995-05-04.
- Submission: K945319
- Applicant / Sponsor: Tetra Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 1995-05-04
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.