K083451 is an FDA 510(k) clearance for the PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS. This device is classified as a Filter, Conduction, Anesthetic (Class II - Special Controls, product code BSN).
Submitted by Smiths Medical Asd, Inc. (Keene, US). The FDA issued a Cleared decision on March 4, 2009, 103 days after receiving the submission on November 21, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5130.
| 510(k) Number | K083451 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2008 |
| Decision Date | March 04, 2009 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSN — Filter, Conduction, Anesthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5130 |