Cytoguard(Tm) Closed Luer Connector
FDA 510(k) K112636 · B.Braun Medical, Inc.
510(k) numberK112636
Submission
- Device name
- Cytoguard(Tm) Closed Luer Connector
- Applicant
- B.Braun Medical, Inc.
Allentown, PA, US - Received
- September 9, 2011
- Decision date
- November 26, 2011
- 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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| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
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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 |
|---|---|---|
| K254111 | Irrigation/Urology SetsLJH · Traditional | 09/10/2026SE |
| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | 05/15/2026SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | 07/24/2025SE |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemDTK · Traditional | 07/31/2024SE |
| K241845 | Introcan Safety® 2 IV CatheterFOZ · Special | 07/26/2024SE |
| K241385 | Omnifix Syringe NRFitQEH · Traditional | 07/13/2024SE |
| K231242 | Perifix FX Catheter; Contiplex FX CatheterBSO · Traditional | 09/15/2023SE |
| K223479 | AQUAbase nXFIP · Traditional | 08/16/2023SE |
| K220756 | Introcan Safety 2 IV CatheterFOZ · Special | 06/23/2022SE |
| K220626 | Introcan Safety IV CatheterFOZ · Special | 05/14/2022SE |
Questions and answers
When was Cytoguard(Tm) Closed Luer Connector cleared by the FDA?
Cytoguard(Tm) Closed Luer Connector (K112636) received a 510(k) decision of Substantially Equivalent on November 26, 2011, 78 days after the submission was received.
What is the product code of K112636?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.