Identifiers
- 510(k) Number
- K063290 FDA 510(k)
- FDA Product Code
- FJK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5820 FDA 510(k)
- Regulation Number
- 876.5820 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve. Gambro Quickset Bloodlines are single-use sterile tubing sets for hemodialysis.
They transport patient blood from vascular access to a dialyzer and return purified blood to the patient. Supplied sterile for single use. Authorized under FDA 510(k) K063290, product code FJK, regulation number 876.5820.
Frequently asked questions
What is the Gambro Quickset Bloodlines used for?
The Gambro Quickset Bloodlines are used to transport patient blood from vascular access to a dialyzer and return purified blood to the patient during hemodialysis treatment. This function is critical for extracorporeal blood circulation in renal replacement therapy.
Is the Gambro Quickset Bloodlines sterile and for single use only?
Yes, the Gambro Quickset Bloodlines are supplied sterile and intended for single use only. This ensures infection control and prevents cross-contamination between patients, as reuse could compromise sterility and material integrity.
Does the Gambro Quickset Bloodlines include an anti-regurgitation valve?
The Gambro Quickset Bloodlines are available in configurations both with and without an anti-regurgitation valve. This valve helps prevent backflow of blood in the tubing set, enhancing safety during hemodialysis procedures.
What regulatory authorization covers the Gambro Quickset Bloodlines?
The Gambro Quickset Bloodlines are authorized under FDA 510(k) submission K063290, which determined them to be substantially equivalent to a legally marketed predicate device. They are classified under product code FJK and regulation number 876.5820.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GAMBRO QUICKSET BLOODLINES (K063290) — FDA 510(k) | Innolitics, PDF 5.0 510(K) SUMMARY - Food and Drug Administration, GAMBRO QUICKSET BLOODLINES 510 (k) K063290 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063290 | Class II | Active |
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Manufacturer
- Manufacturer
- Gambro Renal Products
Sources (1)
- FDA 510(k) K063290 24 fields · synced Sep 26, 2026