D'Vill Introducer
FDA 510(k) K171206 · NuMED, Inc.
510(k) numberK171206
Submission
- Device name
- D'Vill Introducer
- Applicant
- NuMED, Inc.
Hopkinton, NY, US - Received
- April 25, 2017
- Decision date
- October 20, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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Questions and answers
When was D'Vill Introducer cleared by the FDA?
D'Vill Introducer (K171206) received a 510(k) decision of Substantially Equivalent on October 20, 2017, 178 days after the submission was received.
What is the product code of K171206?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.