Radifocus Glidewire
FDA 510(k) K152740 · Ashitaka Factory of Terumo Corp.
510(k) numberK152740
Submission
- Device name
- Radifocus Glidewire
- Applicant
- Ashitaka Factory of Terumo Corp.
Fujinomiya Shizuoka, JP - Received
- September 23, 2015
- Decision date
- November 16, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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Questions and answers
When was Radifocus Glidewire cleared by the FDA?
Radifocus Glidewire (K152740) received a 510(k) decision of Substantially Equivalent on November 16, 2015, 54 days after the submission was received.
What is the product code of K152740?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.