BSN · Filter, Conduction, Anesthetic
Anesthesiology · 21 CFR 868.5130 · Class 2
Overview
| Product Code | BSN |
|---|---|
| Device Name | Filter, Conduction, Anesthetic |
| Regulation | 21 CFR 868.5130 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K190663 | Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 | PAJUNK GmbH Medizintechnologie | Jun 17, 2019 | SESE |
| K133004 | VENTED MILLEX -GV, CATHIVEX -GV | Merck Millipore , Ltd. | Mar 27, 2014 | SESE |
| K083451 | PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS | Smiths Medical Asd, Inc. | Mar 4, 2009 | SESE |
| K023892 | MILLEX VV, GV, AND HV SYRINGE FILTER UNITS | Millipore Corp. | Jan 17, 2003 | SESE |
| K013988 | MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R | Millipore Corp. | Apr 4, 2002 | SESE |
| K963717 | MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) | Millipore Corp. | Jun 10, 1997 | SESE |
| K960928 | SYRINGEFILTER | Arbor Technologies, Inc. | Apr 4, 1997 | SESE |
| K902666 | ANESTHESIA CONDUCTION FILTER | Arbor Technologies, Inc. | Apr 23, 1991 | SESE |
| K780519 | FILTER TUBE | Jelco Laboratories | May 9, 1978 | SESE |
Top Applicants
- Millipore Corp. — 3 clearances
- Arbor Technologies, Inc. — 2 clearances
- Jelco Laboratories — 1 clearance
- Merck Millipore , Ltd. — 1 clearance
- PAJUNK GmbH Medizintechnologie — 1 clearance
