Berlex Bolus/Infusion(Tm) Intravenous Admin Set
FDA 510(k) K905518 · Venusa , Ltd.
510(k) numberK905518
Submission
- Device name
- Berlex Bolus/Infusion(Tm) Intravenous Admin Set
- Applicant
- Venusa , Ltd.
Edison, NJ, US - Received
- December 7, 1990
- Decision date
- June 21, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Berlex Bolus/Infusion(Tm) Intravenous Admin Set cleared by the FDA?
Berlex Bolus/Infusion(Tm) Intravenous Admin Set (K905518) received a 510(k) decision of Substantially Equivalent on June 21, 1991, 196 days after the submission was received.
What is the product code of K905518?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.