Vygon Split Cannula Introducer
FDA 510(k) K010913 · Vygon Corp.
510(k) numberK010913
Submission
- Device name
- Vygon Split Cannula Introducer
- Applicant
- Vygon Corp.
West Cadwell, NJ, US - Received
- March 27, 2001
- Decision date
- September 28, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Vygon Split Cannula Introducer cleared by the FDA?
Vygon Split Cannula Introducer (K010913) received a 510(k) decision of Substantially Equivalent on September 28, 2001, 185 days after the submission was received.
What is the product code of K010913?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.