Medsource IV Administration Set 72 Medsource IV Administration Set, Needleless Male Adapter, Medsource IV Extension Set
FDA 510(k) K140402 · Medsource International, LLC
510(k) numberK140402
Submission
- Device name
- Medsource IV Administration Set 72 Medsource IV Administration Set, Needleless Male Adapter, Medsource IV Extension Set
- Applicant
- Medsource International, LLC
Mound, MN, US - Received
- February 18, 2014
- Decision date
- April 3, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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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|---|---|---|
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| K150611 | MedSource ClearSafe Safety IV CatheterFOZ · Traditional | 07/15/2015SE |
| K150333 | MedSource Sharps DartMMK · Traditional | 05/08/2015SE |
| K140442 | Medsource Selectable IV SetLHI · Special | 04/22/2014SE |
| K131555 | Medsource IV Safety CatheterFOZ · Traditional | 01/31/2014SE |
| K120424 | Medsource IV Adminstration SetLHI · Traditional | 07/11/2012SE |
| K080339 | Medsource Endotracheal Tube (with and Without Cuff)BTR · Traditional | 10/27/2008SE |
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Questions and answers
When was Medsource IV Administration Set 72 Medsource IV Administration Set, Needleless Male Adapter, Medsource IV Extension Set cleared by the FDA?
Medsource IV Administration Set 72 Medsource IV Administration Set, Needleless Male Adapter, Medsource IV Extension Set (K140402) received a 510(k) decision of Substantially Equivalent on April 3, 2014, 44 days after the submission was received.
What is the product code of K140402?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.