Cleared Traditional

PCEA Syringe Set

K211649 · Baxter Healthcare Corporation · General Hospital
Nov 2021
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K211649 is an FDA 510(k) clearance for the PCEA Syringe Set, 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 review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K211649 FDA.gov
FDA Decision Cleared 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

Device Classification

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.