CentriMag Acute Circulatory Support System— 510(k) K191557
Substantially EquivalentThoratec Corporation (Now Part of Abbott)
FDA 510(k) clearance K191557 for CentriMag Acute Circulatory Support System, Substantially Equivalent on 2019-07-10. Applicant: Thoratec Corporation (Now Part of Abbott). Device class: 2.
Clearance details
- Applicant
- Thoratec Corporation (Now Part of Abbott)
- 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
- Pleasanton, CA, US
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- K200306 — CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.