VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT— 510(k) K964907
Substantially EquivalentSorin Biomedical, Inc.
FDA 510(k) clearance K964907 for VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT, Substantially Equivalent on 1997-08-21. Applicant: Sorin Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sorin 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
- Irvine, CA, US
Recent devices under product code DTN
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
- K963759 — DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS
- K964908 — VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
- K961869 — DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
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.