IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR— 510(k) K030154
Substantially EquivalentDideco S.P.A.
FDA 510(k) clearance K030154 for IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR, Substantially Equivalent on 2003-03-31. Applicant: Dideco S.P.A..
Clearance details
- Applicant
- Dideco S.P.A.
- Product code
- Code KFM
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Waltham, MA, US
Adverse events under product code KFM
product code KFM- Death
- 109
- Injury
- 241
- Malfunction
- 1,779
- Total
- 2,129
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.