MEDOS HILITE 7000 & 7000 LT OXYGENATOR— 510(k) K133261
Substantially EquivalentMedos Medizintechnik AG
FDA 510(k) clearance K133261 for MEDOS HILITE 7000 & 7000 LT OXYGENATOR, Substantially Equivalent on 2014-01-09. Applicant: Medos Medizintechnik AG. Device class: 2.
Clearance details
- Applicant
- Medos Medizintechnik AG
- 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
- Special
- Location
- Ann Arbor, MI, US
Recent devices under product code DTZ
view all- K253838 — Lifemotion Disposable Membrane Oxygenator
- K240934 — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3) +2 more
- K250821 — Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300) +2 more
- 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 Medos Medizintechnik AG
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.