NFC Needlefree Y-Site, Model 69970
FDA 510(k) K981547 · Filtertek, Inc.
510(k) numberK981547
Submission
- Device name
- NFC Needlefree Y-Site, Model 69970
- Applicant
- Filtertek, Inc.
Hebron, IL, US - Received
- April 30, 1998
- Decision date
- June 18, 1998
- 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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| 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 |
|---|---|---|
| K981548 | NFC Needlefree Connector Model 69900FPA · Traditional | 06/18/1998SE |
| K914792 | PN 62290 0.22 Micron Micro Infus I.V. Exten SetFPA · Traditional | 01/15/1992SE |
| K912848 | I.V. Filter Extension SetFPB · Traditional | 11/29/1991SE |
| K912394 | Transducer ProtectorFIB · Traditional | 08/30/1991SE |
| K911451 | I.V. Extender SetFPB · Traditional | 06/06/1991SE |
| K904912 | Transducer ProtectorFIB · Traditional | 01/04/1991SE |
| K901409 | Transducer ProtectorFIB · Traditional | 07/27/1990SE |
| K901996 | Filtertek PN 60650 Dialysis Transducer ProtectorFIB · Traditional | 06/01/1990SE |
| K895281 | Transducer ProtectorFIB · Traditional | 11/08/1989SE |
Questions and answers
When was NFC Needlefree Y-Site, Model 69970 cleared by the FDA?
NFC Needlefree Y-Site, Model 69970 (K981547) received a 510(k) decision of Substantially Equivalent on June 18, 1998, 49 days after the submission was received.
What is the product code of K981547?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.