SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS— 510(k) K951247
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K951247 for SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS, Substantially Equivalent on 1995-11-02. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code DTZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4350
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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Adverse events under product code DTZ
product code DTZ- Death
- 182
- Injury
- 422
- Malfunction
- 3,636
- Total
- 4,240
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.