TOTAL PARENTERAL NUTRITION SET BAG— 510(k) K801652

Name: FDA 510(k) clearance K801652
Creator: U.S. Food and Drug Administration
Published: 1980-08-27

Substantially Equivalent

Cutter Laboratories, Inc.

FDA 510(k) clearance K801652 for TOTAL PARENTERAL NUTRITION SET BAG, Substantially Equivalent on 1980-08-27. Applicant: Cutter Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cutter Laboratories, Inc.
Product code: Code KPE
Device class: Class 2
Regulation: 21 CFR 880.5025
Advisory panel: General Hospital
Date received: 1980-07-18
Decision date: 1980-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.