NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER— 510(k) K113227
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K113227 for NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER, Substantially Equivalent on 2011-12-08. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code FPB
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Deerfield, IL, US
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Adverse events under product code FPB
product code FPB- Other
- 1
- Total
- 1
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.