Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6
FDA 510(k) K190663 · PAJUNK GmbH Medizintechnologie
510(k) numberK190663
Submission
- Device name
- Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6
- Applicant
- PAJUNK GmbH Medizintechnologie
Geisingen, DE - Received
- March 15, 2019
- Decision date
- June 17, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSN – Filter, Conduction, Anesthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5130
- Specialty
- Anesthesiology
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|---|---|---|---|
| K133004 | Vented Millex -Gv, Cathivex -GvBSN · Traditional | Merck Millipore , Ltd. | 03/27/2014SE |
| K083451 | Portex Epidural Filter, Model 100/386/010, Various Standard and Custom TraysBSN · Traditional | Smiths Medical Asd, Inc. | 03/04/2009SE |
| K023892 | Millex VV, GV, and HV Syringe Filter UnitsBSN · Traditional | Millipore Corp. | 01/17/2003SE |
| K013988 | Millex GP Sterilizing Filter Unit, Model SLGP 033 RBSN · Special | Millipore Corp. | 04/04/2002SE |
| K963717 | Millex - MP Filter Unit (SLMPO25SS/SLMPL25SS)BSN · Traditional | Millipore Corp. | 06/10/1997SE |
| K960928 | SyringefilterBSN · Traditional | Arbor Technologies, Inc. | 04/04/1997SE |
| K902666 | Anesthesia Conduction FilterBSN · Traditional | Arbor Technologies, Inc. | 04/23/1991SE |
| K780519 | Filter TubeBSN · Traditional | Jelco Laboratories | 05/09/1978SE |
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Questions and answers
When was Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 cleared by the FDA?
Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 (K190663) received a 510(k) decision of Substantially Equivalent on June 17, 2019, 94 days after the submission was received.
What is the product code of K190663?
The FDA product code is BSN – Filter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5130.