TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500— 510(k) K061369
Substantially EquivalentCardiacassist, Inc.
FDA 510(k) clearance K061369 for TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500, Substantially Equivalent on 2006-08-22. Applicant: Cardiacassist, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiacassist, 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
- Pittsburgh, PA, US
Recent devices under product code DWA
view all- K232788 — INSPIRA ART100
- K230698 — Anivia SG1000 Pump Console
- K221491 — Anivia SG1000 Pump Console
- 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
More clearances from Cardiacassist, 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.