Cleared Traditional

K932512 - MULTI-PORT MANIFOLD (FDA 510(k) Clearance)

K932512 · Baxter Healthcare Corp · General Hospital
Feb 1994
Decision
273d
Days
Class 2
Risk

K932512 is an FDA 510(k) clearance for the MULTI-PORT MANIFOLD. This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on February 22, 1994, 273 days after receiving the submission on May 25, 1993.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K932512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1993
Decision Date February 22, 1994
Days to Decision 273 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FMG — Stopcock, I.v. Set
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.5440