DeviceClearance

CLAVE NEUTRON— 510(k) K100434

Substantially Equivalent

Icu Medical, Inc.

FDA 510(k) clearance K100434 for CLAVE NEUTRON, Substantially Equivalent on 2010-07-09. Applicant: Icu Medical, Inc.. Device class: 2.

Clearance details

Applicant
Icu Medical, Inc.
Product code
Code FPA
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Salt Lake City, UT, 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 FPA

product code FPA
Death
95
Injury
14,421
Malfunction
125,815
Other
30
Total
140,361

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 K100434

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 K100434.

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