Pharmacia Deltec Extension Set with Anti-Siphon Valve
FDA 510(k) K942046 · Pharmacia Deltec, Inc.
510(k) numberK942046
Submission
- Device name
- Pharmacia Deltec Extension Set with Anti-Siphon Valve
- Applicant
- Pharmacia Deltec, Inc.
St. Paul, MN, US - Received
- April 28, 1994
- Decision date
- October 4, 1994
- 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 |
|---|---|---|
| K943310 | Model 6100 Ambulatory Infusion SystemMEA · Traditional | 02/21/1995ST |
| K942161 | LockboxFRN · Traditional | 08/02/1994ST |
| K942024 | Port-A-Cath Low Profile Implantable Venous Access SystemLJT · Traditional | 07/26/1994SE |
| K941445 | Extension Set with Anti-Siphon ValveFPA · Traditional | 06/29/1994SE |
| K931073 | Cath-FinderFOZ · Traditional | 05/05/1994SE |
| K932464 | Peripherallyinsrted Venous Cath. Alternate Cath.LJS · Traditional | 05/02/1994SESK |
| K932433 | Pheripherally Inserted Venous Catheter-Y SiteLJS · Traditional | 05/02/1994SESK |
| K932430 | Dual Lumen Peripherally Inserted Venous CatheterLJS · Traditional | 05/02/1994SESK |
| K932211 | Procedural Tray for Peripherally Inserted VenousLJS · Traditional | 05/02/1994SE |
| K932198 | Pharmacia Deltec Peripherally Inserted Venous CathLJS · Traditional | 05/02/1994SESK |
Questions and answers
When was Pharmacia Deltec Extension Set with Anti-Siphon Valve cleared by the FDA?
Pharmacia Deltec Extension Set with Anti-Siphon Valve (K942046) received a 510(k) decision of Substantially Equivalent on October 4, 1994, 159 days after the submission was received.
What is the product code of K942046?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.