MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900— 510(k) K040385
Substantially EquivalentQuest Medical, Inc.
FDA 510(k) clearance K040385 for MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900, Substantially Equivalent on 2004-04-07. Applicant: Quest Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Quest Medical, Inc.
- 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
- Abbreviated
- Location
- Allen, TX, US
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More clearances from Quest Medical, Inc.
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.