BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE— 510(k) K131964
Substantially EquivalentMedtronic, Inc.
FDA 510(k) clearance K131964 for BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE, Substantially Equivalent on 2013-07-24. Applicant: Medtronic, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic, Inc.
- Product code
- Code DWA
- Device class
- Class 2
- Regulation
- 21 CFR 870.4380
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mounds View, MN, US
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More clearances from Medtronic, Inc.
view allAdverse events under product code DWA
product code DWA- Death
- 15
- Malfunction
- 1,654
- Total
- 1,669
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 →
Recalls naming K131964
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131964.
Data sourced from openFDA. This site is unofficial and independent of the FDA.