R2P SlenGuide
FDA 510(k) K161546 · Ashitaka Factory of Terumo Corporation
510(k) numberK161546
Submission
- Device name
- R2P SlenGuide
- Applicant
- Ashitaka Factory of Terumo Corporation
Fujinomiya Shizuoka, JP - Received
- June 3, 2016
- Decision date
- October 14, 2016
- 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 R2P SlenGuide cleared by the FDA?
R2P SlenGuide (K161546) received a 510(k) decision of Substantially Equivalent on October 14, 2016, 133 days after the submission was received.
What is the product code of K161546?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.