Nexus Intravascular Tubing Sets-Pre-Pierced
FDA 510(k) K092930 · Nexus Medical, LLC
510(k) numberK092930
Submission
- Device name
- Nexus Intravascular Tubing Sets-Pre-Pierced
- Applicant
- Nexus Medical, LLC
Lenexa, KS, US - Received
- September 22, 2009
- Decision date
- March 10, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
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| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
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More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K142590 | All Safe Huber Safety Infusion SetFPA · Traditional | 01/16/2015SE |
| K133351 | Nexus NIS-6P Luer Activated DeviceFPA · Traditional | 05/22/2014SE |
| K130879 | Nexus IV Tubing Set with Luer-Accessbile One-Way Check Valve - IV PlusFPA · Traditional | 07/09/2013SE |
| K130416 | Nexus TKO-6P Luer Activated DeviceFPA · Traditional | 06/12/2013SE |
| K113398 | Nexus TKO-6, Luer-Activated DeviceFPA · Traditional | 04/18/2012SE |
| K092382 | Nexus Pressure Rated Extension SetsFPA · Traditional | 04/26/2010SE |
| K092527 | Nexus Injection Site, Model NIS-8FPA · Special | 02/04/2010SE |
| K081123 | Nexus I.V. Needless Access Cannula for Intravascular Administration SetsFPA · Traditional | 11/14/2008SE |
| K080976 | Nexus I.V. Fluid Transfer DeviceLHI · Traditional | 11/10/2008SE |
| K062551 | Nexus Irrigation Tubing SetLJH · Traditional | 12/15/2006SE |
Questions and answers
When was Nexus Intravascular Tubing Sets-Pre-Pierced cleared by the FDA?
Nexus Intravascular Tubing Sets-Pre-Pierced (K092930) received a 510(k) decision of Substantially Equivalent on March 10, 2010, 169 days after the submission was received.
What is the product code of K092930?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.