Device Listing 1214018675

Listing Summary#

Listing key
1214018675
Premarket submission
K243237
Device
2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
Product code
KDI
Decision date
2025-06-13