Data / Medical devices / Netherlands / CD Leycom
CD Leycom: FDA-registered device maker in Hengelo Overijssel, Netherlands, 3 510(k) clearances
CD Leycom is registered with the FDA (registration 3003493679) in Hengelo Overijssel, Netherlands. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 9, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003493679
- Address
- Asveldweg 2, Hengelo Overijssel, Netherlands, 7556 BP
- Owner or operator
- CD Leycom (9043127)
- Roles
- Exporter to the US, Specification developer
- First device listed
- December 28, 2007
- Registered through
- 2026
- Brand names listed
- 4F pressure-volume catheter, 7F pressure-volume catheter, CD Leycom, CFL-M, Cardiac Function Laboratory, Inca, IntraCardiac Analyzer, conductance catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | DRO | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Transducer, Pressure, Catheter Tip | DXO | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 9, 2003 | K031599 | CD LEYCOM PRESSURE/VOLUME CATHETERS | DQO | Substantially Equivalent | Cd Leycom BV | accessdata.fda.gov |
| March 3, 2003 | K030524 | CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN | OBJ | Substantially Equivalent | Cd Leycom BV | accessdata.fda.gov |
| May 11, 2001 | K003020 | CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER | DQO | Substantially Equivalent | Cd Leycom BV | accessdata.fda.gov |
Compare with other makers
- All makers of Amplifier And Signal Conditioner, Transducer Signal
- All makers of Transducer, Pressure, Catheter Tip
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Catheter, Ultrasound, Intravascular
- All makers of Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Updated December 9, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.