K190663 is an FDA 510(k) clearance for the Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6. This device is classified as a Filter, Conduction, Anesthetic (Class II - Special Controls, product code BSN).
Submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on June 17, 2019, 94 days after receiving the submission on March 15, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5130.
| 510(k) Number | K190663 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2019 |
| Decision Date | June 17, 2019 |
| Days to Decision | 94 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 |