SORIN BLOOD CARDIOPLEGIA CONSOLE— 510(k) K942582
Substantially EquivalentSorin Biomedical, Inc.
FDA 510(k) clearance K942582 for SORIN BLOOD CARDIOPLEGIA CONSOLE, Substantially Equivalent on 1995-01-27. Applicant: Sorin Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sorin Biomedical, Inc.
- Product code
- Code DTQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code DTQ
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view all- K990103 — MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE
- K963758 — CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE
- K963759 — DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS
- K964908 — VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
- K964907 — VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT
Adverse events under product code DTQ
product code DTQ- Death
- 123
- Malfunction
- 4,822
- Other
- 1
- Total
- 4,946
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.