VLV SA Ef Infusion Port
FDA 510(k) K953791 · Vlv Associates, Inc.
510(k) numberK953791
Submission
- Device name
- VLV SA Ef Infusion Port
- Applicant
- Vlv Associates, Inc.
East Hanover, NJ, US - Received
- August 14, 1995
- Decision date
- October 30, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code FPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K972957 | Sa-Ef Multi-Lumen Extension SetFPA · Traditional | 09/29/1997SE |
| K964876 | Sa.Ef(Tm) Infusion Port II - Connector and Extension SetFPA · Traditional | 02/28/1997SE |
| K955783 | VLV Sa.Ef Infusion Port Extension SetsFPA · Traditional | 02/07/1996SE |
| K945592 | VLV Solodraw(Tm) Dual Chamber Piston SyringeFMF · Traditional | 07/14/1995SE |
| K940406 | Disposable, Ambulatory, Infusion PumpsMEB · Traditional | 09/02/1994ST |
| K933364 | Promed Biopsy NeedleDWO · Traditional | 02/15/1994SE |
| K922469 | Pro-Lok Extension Set(S)FPA · Traditional | 03/15/1993SE |
| K904217 | Pro-Lok (TM) Extension SetsFPA · Traditional | 10/03/1990SE |
| K901081 | Pro-Lock(Tm) Shielding Needle Connector AssemblyFPA · Traditional | 06/08/1990SE |
| K901046 | Versa-Lock(Tm) Universal Needle ConnectorFPA · Traditional | 06/08/1990SE |
Questions and answers
When was VLV SA Ef Infusion Port cleared by the FDA?
VLV SA Ef Infusion Port (K953791) received a 510(k) decision of Substantially Equivalent on October 30, 1995, 77 days after the submission was received.
What is the product code of K953791?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.