EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM— 510(k) K932208
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K932208 for EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM, Substantially Equivalent on 1994-08-09. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code DWF
- Device class
- Class 2
- Regulation
- 21 CFR 870.4210
- 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 DWF
product code DWF- Death
- 106
- Injury
- 386
- Malfunction
- 2,323
- Total
- 2,815
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.