Golden-Rule Scaling Catheter
FDA 510(k) K002416 · Medical Device Technologies, Inc.
510(k) numberK002416
Submission
- Device name
- Golden-Rule Scaling Catheter
- Applicant
- Medical Device Technologies, Inc.
Gainesville, FL, US - Received
- August 8, 2000
- Decision date
- September 11, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was Golden-Rule Scaling Catheter cleared by the FDA?
Golden-Rule Scaling Catheter (K002416) received a 510(k) decision of Substantially Equivalent on September 11, 2000, 34 days after the submission was received.
What is the product code of K002416?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.