UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT— 510(k) K941225
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K941225 for UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT, Substantially Equivalent on 1994-08-16. 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.