Venusa, Ltd. Extension Set with Filter
FDA 510(k) K994429 · Venusa , Ltd.
510(k) numberK994429
Submission
- Device name
- Venusa, Ltd. Extension Set with Filter
- Applicant
- Venusa , Ltd.
El Paso, TX, US - Received
- December 30, 1999
- Decision date
- March 3, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
| K251375 | PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional | Puracath Medical, Inc. | 02/12/2026SE |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
| K251854 | SteadiSet infusion setFPA · Abbreviated | Tandem Diabetes Care | 08/06/2025SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | Deka Research and Development | 08/01/2025SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981683 | Huber Needle Infusion Set Model #20G01 & Y-Site Model #20G01YFPA · Traditional | 07/28/1998SE |
| K905518 | Berlex Bolus/Infusion(Tm) Intravenous Admin SetIZI · Traditional | 06/21/1991SE |
| K851975 | Enteral Feeding Bag, 1000 ML, & Tubing SetKNT · Traditional | 09/05/1985SE |
| K843692 | Flu Ven I.V. Set 0153-C Perma-SetFPA · Traditional | 10/31/1984SE |
| K842088 | Flu Met 2FPA · Traditional | 08/17/1984SE |
| K812981 | Fluven Sets (EXT-1, EXT-2, EXT-3, EXT-4)FPK · Traditional | 11/06/1981SE |
| K811914 | Flu Ven I.V. SetsFPA · Traditional | 08/03/1981SE |
Questions and answers
When was Venusa, Ltd. Extension Set with Filter cleared by the FDA?
Venusa, Ltd. Extension Set with Filter (K994429) received a 510(k) decision of Substantially Equivalent on March 3, 2000, 64 days after the submission was received.
What is the product code of K994429?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.