510(k) K080807 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
BLOOD TUBING SETS (STERILE FLUID PATH)
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Jul 18, 2008 |
| Received | Mar 21, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080807
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2026 | B Braun Medical Inc B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR.
Model Number: SL-2010M2096A. Open, Classified |
FJK | None listed |
| Apr 15, 2026 | B Braun Medical Inc B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096 Open, Classified |
FJK | None listed |
| Apr 15, 2026 | B Braun Medical Inc B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA. Open, Classified |
FJK | None listed |
| Apr 15, 2026 | B Braun Medical Inc B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L. Open, Classified |
FJK | None listed |
| Apr 15, 2026 | B Braun Medical Inc B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705. Open, Classified |
FJK | None listed |
| Apr 15, 2026 | B Braun Medical Inc B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705. Open, Classified |
FJK | None listed |
| Oct 22, 2025 | B BRAUN MEDICAL INC Brand Name: Hemodialysis Bloodlines
Product Name: STREAMLINE BLOODLINE SET FOR DIALOG
Model/Catalog Number: SL-2010M2096
Software Version: N/A
Product Description: STREAMLINE BLOODLINE SET FOR DIALOG
Open, Classified |
FJK | None listed |
| Sep 19, 2024 | B Braun Medical Inc SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Model/Catalog Number: SL-2000M2095 Open, Classified |
FJK | None listed |
| Sep 19, 2024 | B Braun Medical Inc STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Model/Catalog Number: SL-2000M2095D Open, Classified |
FJK | None listed |
| Sep 19, 2024 | B Braun Medical Inc STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Model/Catalog Number: SL-2000M2095DA Open, Classified |
FJK | None listed |
| Sep 19, 2024 | B Braun Medical Inc STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Model/Catalog Number: SL-2000M2095L Open, Classified |
FJK | None listed |
| Sep 19, 2024 | B Braun Medical Inc STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Model/Catalog Number: SL-2000M2095W Open, Classified |
FJK | None listed |
| Sep 19, 2024 | B Braun Medical Inc STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Model/Catalog Number: SL-2010M2096 Open, Classified |
FJK | None listed |
| Sep 19, 2024 | B Braun Medical Inc STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.
Model/Catalog Number: SL-2010M2096A Open, Classified |
FJK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.