PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS
FDA 510(k) clearance K083451 · decided 2009-03-04
Clearance details
- K-number
- K083451
- Device name
- PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS
- Applicant
- Smiths Medical Asd, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-21
- Decision date
- 2009-03-04
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- BSN
- Device class
- 2
- Regulation number
- 868.5130
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Keene, NH, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
| SYRINGEFILTER (K960928) | Arbor Technologies, Inc. | 1997-04-04 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S018) | Smiths Medical Asd, Inc. | 2013-05-13 |
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S017) | Smiths Medical Asd, Inc. | 2010-04-21 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S016) | Smiths Medical Asd, Inc. | 2009-04-20 |
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S015) | Smiths Medical Asd, Inc. | 2007-11-06 |
| PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S014) | Smiths Medical Asd, Inc. | 2007-08-28 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S013) | Smiths Medical Asd, Inc. | 2007-04-05 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM (P900052/S012) | Smiths Medical Asd, Inc. | 2002-12-17 |
| PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S011) | Smiths Medical Asd, Inc. | 2002-10-03 |