Filter Tube
FDA 510(k) K780519 · Jelco Laboratories
510(k) numberK780519
Submission
- Device name
- Filter Tube
- Applicant
- Jelco Laboratories
Mchenry, IL, US - Received
- March 31, 1978
- Decision date
- May 9, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BSN – Filter, Conduction, Anesthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5130
- Specialty
- Anesthesiology
Other 510(k)s with product code BSN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190663 | Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6BSN · Traditional | PAJUNK GmbH Medizintechnologie | 06/17/2019SE |
| 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 |
More from Arbor Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K791918 | Jelco Winged Intravascular CatheterFOZ · Traditional | 10/02/1979SE |
| K791372 | Jelco & Kvo Catheter Placement UnitJCY · Traditional | 09/12/1979SE |
| K790967 | Catheter Metal Hub/RadiopaqueFOZ · Traditional | 06/27/1979SE |
| K790968 | Catheter Metal Hub/NonradiopaqueFOZ · Traditional | 06/11/1979SE |
| K790471 | Jelco* Disc FILTER-0.2 MicronFPB · Traditional | 04/30/1979SE |
| K790186 | ProtectivstabilizerGBJ · Traditional | 02/26/1979SE |
| K790107 | Catheter Tubing ModificationDQO · Traditional | 02/01/1979SE |
| K790079 | Needle, Blood CollectingGAA · Traditional | 02/01/1979SE |
| K781857 | Tray, Arterial Blood Gas SamplingCBT · Traditional | 12/11/1978SE |
| K780896 | Needles, Design Change, IV CathetersGCB · Traditional | 08/23/1978SE |
Questions and answers
When was Filter Tube cleared by the FDA?
Filter Tube (K780519) received a 510(k) decision of Substantially Equivalent on May 9, 1978, 39 days after the submission was received.
What is the product code of K780519?
The FDA product code is BSN – Filter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5130.