Alaris Safety Male Luer
FDA 510(k) K053049 · Cardinal Health, Alaris Products
510(k) numberK053049
Submission
- Device name
- Alaris Safety Male Luer
- Applicant
- Cardinal Health, Alaris Products
San Diego, CA, US - Received
- October 28, 2005
- Decision date
- January 12, 2006
- 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 |
|---|---|---|
| K071400 | Smartsite StopcockFMG · Traditional | 12/14/2007SE |
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| K061285 | Smartsite Needle Free Valve Administration SetsFPA · Traditional | 07/26/2006SE |
| K052790 | Smartsite Vented Vial Access Device, Model TBDLHI · Traditional | 12/23/2005SE |
| K051641 | Alaris System PC Unit, Model 8001FRN · Traditional | 10/20/2005SE |
| K050115 | Blood Hand Pump Administration SetBRZ · Traditional | 04/01/2005SE |
| K043590 | Se Infusion System with MMSFRN · Traditional | 03/25/2005SE |
| K050230 | Turbo Temp TrioFLL · Traditional | 02/16/2005SE |
Questions and answers
When was Alaris Safety Male Luer cleared by the FDA?
Alaris Safety Male Luer (K053049) received a 510(k) decision of Substantially Equivalent on January 12, 2006, 76 days after the submission was received.
What is the product code of K053049?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.