ONE TIME VIAL ACCESS SPIKE— 510(k) K934561

Name: FDA 510(k) clearance K934561
Creator: U.S. Food and Drug Administration
Published: 1994-02-10

Substantially Equivalent

Icu Medical, Inc.

FDA 510(k) clearance K934561 for ONE TIME VIAL ACCESS SPIKE, Substantially Equivalent on 1994-02-10. Applicant: Icu Medical, Inc.. Device class: 2.

Clearance details

Applicant: Icu Medical, Inc.
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 1993-09-21
Decision date: 1994-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.