MEDOS HILITE RESERVOIR, MODEL: 4030— 510(k) K083131
Substantially EquivalentGish Biomedical, Inc.
FDA 510(k) clearance K083131 for MEDOS HILITE RESERVOIR, MODEL: 4030, Substantially Equivalent on 2009-07-30. Applicant: Gish Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Gish Biomedical, Inc.
- Product code
- Code DTN
- Device class
- Class 2
- Regulation
- 21 CFR 870.4400
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rancho Santa Margarita, CA, US
Recent devices under product code DTN
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view all- K090449 — MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT
- K090450 — MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT
- K091062 — MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
- K082403 — MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT
- K081947 — GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
Adverse events under product code DTN
product code DTN- Death
- 3
- Total
- 3
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.