CURITY I.V. START KIT— 510(k) K842898

Substantially Equivalent

The Kendal Co.

FDA 510(k) clearance K842898 for CURITY I.V. START KIT, Substantially Equivalent on 1984-08-17. Applicant: The Kendal Co.. Device class: 2.

Clearance details

Applicant
The Kendal Co.
Product code
Code LRS
Device class
Class 2
Regulation
21 CFR 880.5200
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LRS

product code LRS
Other
2
Total
2

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 K842898

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 K842898.

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