NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET— 510(k) K964812
Substantially EquivalentCritical 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.. 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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- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Critical Device Corp.
view all- K983926 — MPS GRAVITY FLOW CONTROL SET
- K964918 — NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
- K964989 — CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)
- K952852 — NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET
- K955896 — MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.