CELSTAT— 510(k) K103245
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K103245 for CELSTAT, Substantially Equivalent on 2011-03-23. Applicant: Baxter Healthcare Corp. Device class: Unclassified.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code QSY
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcgaw Park, IL, US
Recent devices under product code QSY
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Adverse events under product code QSY
product code QSY- Death
- 5
- Other
- 1
- Total
- 6
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.