Viggo Connecta 3-WAY Infusion Stopcock
FDA 510(k) K850280 · Viggo Products
510(k) numberK850280
Submission
- Device name
- Viggo Connecta 3-WAY Infusion Stopcock
- Applicant
- Viggo Products
Madison, WI, US - Received
- January 23, 1985
- Decision date
- April 11, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMG – Stopcock, I.V. Set
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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|---|---|---|---|
| K242255 | Qitexio® 4-Way Stopcock (QIT014)FMG · Traditional | Medex | 04/29/2025SE |
| K223499 | Three Way Stop CockFMG · Traditional | M/S Romsons International | 07/21/2023SE |
| K223175 | lntravascular Administration Sets with Stopcock and ManifoldFMG · Traditional | Baxter Healthcare Corporation | 03/10/2023SE |
| K211204 | SafePort(TM) Manifold (or Stopcock)FMG · Traditional | Elcam Medical Acal | 09/15/2022SE |
| K210516 | Clicky CrossFMG · Traditional | Yomura Technologies, Inc. | 05/16/2022SE |
| K190539 | TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal…FMG · Traditional | Monumedical, LLC | 10/22/2019SE |
| K190489 | Elcam Stopcocks and ManifoldsFMG · Special | Elcam Medical Acal | 04/23/2019SE |
| K172266 | Dynarex Three-Way StopcockFMG · Traditional | Dynarex Corporation | 03/14/2018SE |
| K141254 | Elcam Stopcocks and ManifoldsFMG · Special | Elcam Medical Acal | 07/30/2014SE |
| K123084 | Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold…FMG · Traditional | Elcam Medical Acal | 05/23/2013SE |
More from Elcam Medical Acal
| 510(k) | Device | Decision |
|---|---|---|
| K850769 | Viggo Accessories for I.V. TherapyFPA · Traditional | 05/29/1985SE |
| K850277 | Viggo I.V. Accessories-Viggo Extension Tubes Etc.FPA · Traditional | 04/12/1985SE |
| K850276 | Viggo Neoflon Infusion CannulaFOZ · Traditional | 04/12/1985SE |
| K850460 | Viggo Secalon T CatheterFOZ · Traditional | 04/11/1985SE |
| K850349 | Viggo Arterial CannulaFOZ · Traditional | 04/09/1985SE |
| K850278 | Vasculon I.V. CannulaeFOZ · Traditional | 04/09/1985SE |
Questions and answers
When was Viggo Connecta 3-WAY Infusion Stopcock cleared by the FDA?
Viggo Connecta 3-WAY Infusion Stopcock (K850280) received a 510(k) decision of Substantially Equivalent on April 11, 1985, 78 days after the submission was received.
What is the product code of K850280?
The FDA product code is FMG – Stopcock, I.V. Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.