PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK— 510(k) K011336

Substantially Equivalent

Churchill Medical Systems, Inc.

FDA 510(k) clearance K011336 for PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK, Substantially Equivalent on 2001-06-12. Applicant: Churchill Medical Systems, Inc..

Clearance details

Applicant: Churchill Medical Systems, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2001-05-02
Decision date: 2001-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, NH, US

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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, 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.