DIDECO PEDIATRIC ARTERIAL FILTERS— 510(k) K945198
Substantially EquivalentSorin Biomedical, Inc.
FDA 510(k) clearance K945198 for DIDECO PEDIATRIC ARTERIAL FILTERS, Substantially Equivalent on 1995-06-27. Applicant: Sorin Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sorin Biomedical, Inc.
- Product code
- Code DTM
- Device class
- Class 2
- Regulation
- 21 CFR 870.4260
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code DTM
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
- K964907 — VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT
Data sourced from openFDA. This site is unofficial and independent of the FDA.