DeviceClearance

Plum Duo Infusion System— 510(k) K223607

Substantially Equivalent

Icu Medical, Inc.

FDA 510(k) clearance K223607 for Plum Duo Infusion System, Substantially Equivalent on 2023-08-24. Applicant: Icu Medical, Inc.. Device class: 2.

Clearance details

Applicant
Icu Medical, Inc.
Product code
Code FRN
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lake Forest, IL, US
Download summary PDFView on FDA.gov ↗

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More clearances from Icu Medical, Inc.

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Adverse events under product code FRN

product code FRN
Death
540
Injury
6,178
Malfunction
1,464,165
Other
52
Total
1,470,935

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

Recalls naming K223607

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223607.

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