GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING— 510(k) K081838
Substantially EquivalentGish Biomedical, Inc.
FDA 510(k) clearance K081838 for GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING, Substantially Equivalent on 2009-01-26. Applicant: Gish Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Gish Biomedical, Inc.
- Product code
- Code DTR
- Device class
- Class 2
- Regulation
- 21 CFR 870.4240
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rancho Santa Margarita, CA, US
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More clearances from Gish Biomedical, Inc.
view allAdverse events under product code DTR
product code DTR- Other
- 1
- Total
- 1
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.