NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET— 510(k) K964812

Substantially Equivalent

Critical Device Corp.

FDA 510(k) clearance K964812 for NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET, Substantially Equivalent on 1997-02-10. Applicant: Critical Device Corp..

Clearance details

Applicant: Critical Device Corp.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1996-11-29
Decision date: 1997-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, 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.