SYRINGEFILTER
FDA 510(k) clearance K960928 · decided 1997-04-04
Clearance details
- K-number
- K960928
- Device name
- SYRINGEFILTER
- Applicant
- Arbor Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-03-07
- Decision date
- 1997-04-04
- Days to decision
- 393 days
- Clearance type
- Traditional
- Product code
- BSN
- Device class
- 2
- Regulation number
- 868.5130
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 (K190663) | PAJUNK GmbH Medizintechnologie | 2019-06-17 |
| VENTED MILLEX -GV, CATHIVEX -GV (K133004) | Merck Millipore , Ltd. | 2014-03-27 |
| PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS (K083451) | Smiths Medical Asd, Inc. | 2009-03-04 |
| MILLEX VV, GV, AND HV SYRINGE FILTER UNITS (K023892) | Millipore Corp. | 2003-01-17 |
| MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R (K013988) | Millipore Corp. | 2002-04-04 |
| MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) (K963717) | Millipore Corp. | 1997-06-10 |
| ANESTHESIA CONDUCTION FILTER (K902666) | Arbor Technologies, Inc. | 1991-04-23 |
| FILTER TUBE (K780519) | Jelco Laboratories | 1978-05-09 |
Recalls involving this device
No recalls on record reference this clearance.