NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS— 510(k) K964918
Substantially EquivalentCritical Device Corp.
FDA 510(k) clearance K964918 for NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS, Substantially Equivalent on 1997-04-14. Applicant: Critical Device Corp.. Device class: 2.
Clearance details
- Applicant
- Critical Device Corp.
- 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
- Brea, CA, US
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More clearances from Critical Device Corp.
view allAdverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.