Radifocus Optitorque Angiographic Catheter
FDA 510(k) K150232 · Ashitaka Factory of Terumo Corp.
510(k) numberK150232
Submission
- Device name
- Radifocus Optitorque Angiographic Catheter
- Applicant
- Ashitaka Factory of Terumo Corp.
Fujinomiya Shizuoka, JP - Received
- February 2, 2015
- Decision date
- October 19, 2015
- 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 Radifocus Optitorque Angiographic Catheter cleared by the FDA?
Radifocus Optitorque Angiographic Catheter (K150232) received a 510(k) decision of Substantially Equivalent on October 19, 2015, 259 days after the submission was received.
What is the product code of K150232?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.