Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
FDA 510(k) K171118 · Cair Lgl
510(k) numberK171118
Submission
- Device name
- Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
- Applicant
- Cair Lgl
Lissieu, FR - Received
- April 14, 2017
- Decision date
- August 15, 2017
- 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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More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K231299 | Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connectorPIO · Traditional | 01/22/2024SE |
| K231300 | Nutricair Enteral Syringe with ENFitPNR · Traditional | 10/06/2023SE |
| K213258 | Nasogastric Feeding Tubes - ENFit Port - PVCPIF · Traditional | 06/09/2022SE |
| K210598 | Pediatric Nasogastric Feeding Tubes - Single ENFit PortPIF · Traditional | 11/02/2021SE |
| K171117 | Carefusion NeutraClear Needle-free connector (EL-NC1000)FPA · Traditional | 09/01/2017SE |
| K171132 | Carefusion NeutraClear Needle-free connectorFPA · Special | 07/31/2017SE |
| K133073 | Cair Drive, NeutraclearFPA · Traditional | 03/20/2014SE |
Questions and answers
When was Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) cleared by the FDA?
Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) (K171118) received a 510(k) decision of Substantially Equivalent on August 15, 2017, 123 days after the submission was received.
What is the product code of K171118?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.