CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR— 510(k) K131179
Substantially EquivalentThoratec Corp
FDA 510(k) clearance K131179 for CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR, Substantially Equivalent on 2013-07-18. Applicant: Thoratec Corp. Device class: 2.
Clearance details
- Applicant
- Thoratec Corp
- 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
- Burlington, MA, US
Recent devices under product code DWA
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- K230698 — Anivia SG1000 Pump Console
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- K192838 — Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
- 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 →
Recalls naming K131179
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 K131179.
Data sourced from openFDA. This site is unofficial and independent of the FDA.