Submission Details
| 510(k) Number | K083451 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS
Mar 2009
Decision
103d
Days
Class 2
Risk
About This 510(k) Submission
K083451 is an FDA 510(k) clearance for the PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS, 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 review panel. Regulated under 21 CFR 868.5130.
Device Classification
| Product Code | BSN — Filter, Conduction, Anesthetic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5130 |
Manufacturer
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