CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)— 510(k) K964989
Substantially EquivalentCritical Device Corp.
FDA 510(k) clearance K964989 for CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5), Substantially Equivalent on 1997-04-02. Applicant: Critical Device Corp.. Device class: 2.
Clearance details
- Applicant
- Critical Device Corp.
- Product code
- Code LHI
- 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
Recent devices under product code LHI
view allMore 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
- K964812 — NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET
- K952852 — NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET
- K955896 — MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11
Adverse events under product code LHI
product code LHI- Injury
- 207
- Malfunction
- 7,820
- Other
- 3
- Total
- 8,030
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.