SWAN-GANZ FLOW-DIRECTED CATHETER— 510(k) K791183
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K791183 for SWAN-GANZ FLOW-DIRECTED CATHETER, Substantially Equivalent on 1979-07-12. Applicant: Edwards Lifesciences, LLC. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Code LDF
- Device class
- Class 2
- Regulation
- 21 CFR 870.3680
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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More clearances from Edwards Lifesciences, LLC
view allAdverse events under product code LDF
product code LDF- Death
- 19
- Injury
- 188
- Malfunction
- 694
- Other
- 1
- Total
- 902
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.