DeviceClearance

CADD® Infusion Disposables Portfolio with NRFit connectors— 510(k) K162219

Substantially Equivalent

Smiths Medical Asd, Inc.

FDA 510(k) clearance K162219 for CADD® Infusion Disposables Portfolio with NRFit connectors, Substantially Equivalent on 2017-07-20. Applicant: Smiths Medical Asd, Inc.. Device class: 2.

Clearance details

Applicant
Smiths Medical Asd, Inc.
Product code
Product code PWH
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Plymouth, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code PWH

product code PWH
Other
1
Total
1

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 K162219

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 K162219.

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