DUAL COMPARTMENT TPN BAG 3 LITER— 510(k) K911567

Name: FDA 510(k) clearance K911567
Creator: U.S. Food and Drug Administration
Published: 1991-08-02

Substantially Equivalent

Stedim, Inc.

FDA 510(k) clearance K911567 for DUAL COMPARTMENT TPN BAG 3 LITER, Substantially Equivalent on 1991-08-02. Applicant: Stedim, Inc.. Device class: 2.

Clearance details

Applicant: Stedim, Inc.
Product code: Code KPE
Device class: Class 2
Regulation: 21 CFR 880.5025
Advisory panel: General Hospital
Date received: 1991-04-09
Decision date: 1991-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.