Add-Vantage Addaptor
FDA 510(k) K133602 · Hospira, Inc.
510(k) numberK133602
Submission
- Device name
- Add-Vantage Addaptor
- Applicant
- Hospira, Inc.
Lake Forest, IL, US - Received
- November 25, 2013
- Decision date
- January 24, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K160870 | Hospira Administration SetsFPA · Special | 06/01/2016SE |
| K143612 | LifeCare PCA Infusion SystemMEA · Traditional | 04/08/2016SE |
| K143087 | Hospira Blood SetFPA · Traditional | 03/04/2015SE |
| K143015 | Hospira Primary SetsFPA · Traditional | 02/25/2015SE |
| K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play Ce 3.0 Module for…FRN · Traditional | 01/16/2015SE |
| K142622 | IV AdministrationFPA · Traditional | 01/15/2015SE |
| K142974 | Extension SetsFPA · Traditional | 01/09/2015SE |
Questions and answers
When was Add-Vantage Addaptor cleared by the FDA?
Add-Vantage Addaptor (K133602) received a 510(k) decision of Substantially Equivalent on January 24, 2014, 60 days after the submission was received.
What is the product code of K133602?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.