Data / Medical devices / Netherlands / Pendracare International B.V.
Pendracare International B.V.: FDA-registered device maker in Leek Groningen, Netherlands, 3 510(k) clearances
Pendracare International B.V. is registered with the FDA (registration 3005635992) in Leek Groningen, Netherlands. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated June 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005635992
- Address
- Van der Waalspark 22, Leek Groningen, Netherlands, 9351 VC
- Owner or operator
- PendraCare International B.V. (10041705)
- Roles
- Manufacturer
- First device listed
- August 22, 2012
- Registered through
- 2026
- Brand names listed
- Climber Hydrophilic Guiding Catheter, Convey 5F Guiding Catheter, Convey 6F Guiding Catheter, Convey 7F Guiding Catheter, Convey 8F Guiding Catheter, Primum Hydrophilic Guiding Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 29, 2025 | K250972 | Primum Hydrophilic Guiding Catheter | DQY | Substantially Equivalent | Pendracare | accessdata.fda.gov |
| August 12, 2013 | K132197 | CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER | DQY | Substantially Equivalent | Pendracare International, B.V. | accessdata.fda.gov |
| August 8, 2012 | K120585 | CONVEY GUIDING CATHETER | DQY | Substantially Equivalent | Pendracare International, B.V. | accessdata.fda.gov |
Compare with other makers
Updated June 29, 2025. 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.