DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS— 510(k) K963759
Substantially EquivalentSorin Biomedical, Inc.
FDA 510(k) clearance K963759 for DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS, 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
view allMore clearances from Sorin Biomedical, Inc.
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
- 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.