SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS— 510(k) K913526
Substantially EquivalentAlthin Medical AB an Affiliate of Baxter Intl
FDA 510(k) clearance K913526 for SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS, Substantially Equivalent on 1991-11-01. Applicant: Althin Medical AB an Affiliate of Baxter Intl. Device class: 2.
Clearance details
- Applicant
- Althin Medical AB an Affiliate of Baxter Intl
- Product code
- Code FJK
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami Lakes, FL, US
Recent devices under product code FJK
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view all- K990643 — PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015
- K970679 — ALTRA FLUX 200 HEMODIALYZER
- K970681 — ALTRA NOVA 200 HEMODIALYZER
- K970446 — DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM
- K964922 — DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM
Adverse events under product code FJK
product code FJK- Death
- 52
- Malfunction
- 3,430
- Total
- 3,482
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.