CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE— 510(k) K963758
Substantially EquivalentSorin Biomedical, Inc.
FDA 510(k) clearance K963758 for CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE, Substantially Equivalent on 1998-02-20. Applicant: Sorin Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sorin Biomedical, Inc.
- Product code
- Code CAC
- Device class
- Class 2
- Regulation
- 21 CFR 868.5830
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code CAC
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- 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
- K961869 — DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
Adverse events under product code CAC
product code CAC- Death
- 11
- Malfunction
- 477
- Total
- 488
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.