MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT— 510(k) K090450
Substantially EquivalentGish Biomedical, Inc.
FDA 510(k) clearance K090450 for MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT, Substantially Equivalent on 2009-09-18. Applicant: Gish Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Gish Biomedical, 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
- Rancho Santa Margarita, CA, US
Recent devices under product code DTZ
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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 Gish Biomedical, 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.