510(k) K042388
K042388 is an FDA 510(k) premarket notification submitted by Radiant Medical for the device "RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE". The FDA issued a decision of Substantially Equivalent on October 28, 2004. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Radiant Medical has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2004
- Date Received
- September 2, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type