MPS GRAVITY FLOW CONTROL SET— 510(k) K983926
Substantially EquivalentCritical Device Corp.
FDA 510(k) clearance K983926 for MPS GRAVITY FLOW CONTROL SET, Substantially Equivalent on 1999-01-20. 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)
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More clearances from Critical Device Corp.
view all- 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)
- 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 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.