Clearance Summary
3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE received FDA 510(k) clearance under submission number K020365, sponsored by 3t Medical Systems, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-05-03.
- Submission: K020365
- Applicant / Sponsor: 3t Medical Systems, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4200
- Decision date: 2002-05-03
Classification & Regulation
This clearance is catalogued under FDA product code KRI and 21 CFR 870.4200, within the Cardiovascular review panel as a Class I device.