Radiant Medical Endocatheter Temperature Probe
FDA 510(k) K042388 · Radiant Medical
510(k) numberK042388
Submission
- Device name
- Radiant Medical Endocatheter Temperature Probe
- Applicant
- Radiant Medical
Redwood City, CA, US - Received
- September 2, 2004
- Decision date
- October 28, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was Radiant Medical Endocatheter Temperature Probe cleared by the FDA?
Radiant Medical Endocatheter Temperature Probe (K042388) received a 510(k) decision of Substantially Equivalent on October 28, 2004, 56 days after the submission was received.
What is the product code of K042388?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.