TandemLung Oxygenator— 510(k) K153295
Substantially EquivalentCardiacassist, Inc.
FDA 510(k) clearance K153295 for TandemLung Oxygenator, Substantially Equivalent on 2016-02-26. Applicant: Cardiacassist, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiacassist, Inc.
- Product code
- Code DTZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4350
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pittsburgh, PA, US
Recent devices under product code DTZ
view all- K253838 — Lifemotion Disposable Membrane Oxygenator
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- K242503 — Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
- K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
More clearances from Cardiacassist, Inc.
view allAdverse events under product code DTZ
product code DTZ- Death
- 182
- Injury
- 422
- Malfunction
- 3,636
- Total
- 4,240
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.