STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP— 510(k) K994209
Substantially EquivalentCobe Cardiovascular, Inc.
FDA 510(k) clearance K994209 for STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP, Substantially Equivalent on 2000-06-14. Applicant: Cobe Cardiovascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Cobe Cardiovascular, Inc.
- 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
- Abbreviated
- Location
- Arvada, CO, 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.