IMPELLA 5.0 CATHETER FAMILY— 510(k) K083111
Substantially EquivalentAbiomed, Inc.
FDA 510(k) clearance K083111 for IMPELLA 5.0 CATHETER FAMILY, Substantially Equivalent on 2009-04-16. Applicant: Abiomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Abiomed, Inc.
- Product code
- Code KFM
- Device class
- Class 2
- Regulation
- 21 CFR 870.4360
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danvers, MA, US
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More clearances from Abiomed, Inc.
view allAdverse 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.