K162219 is an FDA 510(k) clearance for the CADD® Infusion Disposables Portfolio with NRFit™ connectors. This device is classified as a Administrations Sets With Neuraxial Connectors (Class II - Special Controls, product code PWH).
Submitted by Smiths Medical Asd, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 20, 2017, 346 days after receiving the submission on August 8, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440. The Connector For Neuraxial Applications Is Intended To Facilitate Ansi/aami/iso 80369-6:2016 Compliant Neuraxial Specific Connections..
| 510(k) Number | K162219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2016 |
| Decision Date | July 20, 2017 |
| Days to Decision | 346 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PWH — Administrations Sets With Neuraxial Connectors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
| Definition | The Connector For Neuraxial Applications Is Intended To Facilitate Ansi/aami/iso 80369-6:2016 Compliant Neuraxial Specific Connections. |