K211649 is an FDA 510(k) clearance for the PCEA Syringe Set. This device is classified as a Administrations Sets With Neuraxial Connectors (Class II - Special Controls, product code PWH).
Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on November 23, 2021, 179 days after receiving the submission on May 28, 2021.
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 | K211649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 2021 |
| Decision Date | November 23, 2021 |
| Days to Decision | 179 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. |