Identifiers
- 510(k) Number
- K884609 FDA 510(k)
- FDA Product Code
- KDL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5880 FDA 510(k)
- Regulation Number
- 876.5880 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Set, Perfusion, Kidney, Disposable as classified by the FDA. It is identified by the product code KDL and regulation number 876.5880.
The device is supplied as a disposable set and has received FDA 510(k) clearance under number K884609, with a decision of substantially equivalent. It is classified as a Class II medical device and is associated with the gastroenterology and urology medical specialties.
Frequently asked questions
What is the EURO-COLLINS SOLUTION SETS used for?
The EURO-COLLINS SOLUTION SETS is a disposable kidney perfusion set designed for use in gastroenterology and urology procedures, specifically for perfusing kidneys during clinical interventions as classified under FDA product code KDL and regulation 876.5880.
Is the EURO-COLLINS SOLUTION SETS sterile and single-use?
Yes, the device is supplied as a disposable set, indicating it is intended for single-use only and provided in a sterile condition to ensure patient safety and prevent cross-contamination during kidney perfusion procedures.
What regulatory clearance does the EURO-COLLINS SOLUTION SETS have?
The device has received FDA 510(k) clearance under number K884609 with a decision of substantially equivalent, classifying it as a Class II medical device under the gastroenterology and urology specialties.
Who manufactures the EURO-COLLINS SOLUTION SETS and where is it located?
The EURO-COLLINS SOLUTION SETS is manufactured by Fresenius USA, Inc., with administrative address listed as Verwaltung: Borkenberg 14, 6370 Oberursel/Taunus 1, Germany.
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: EURO-COLLINS SOLUTION SETS (K884609) — FDA 510(k) | Innolitics, EURO-COLLINS SOLUTION SETS 510(k) K884609 - FDA.report, PDF K884609 - Euro-collins Solution Sets, Euro-collins Solution Sets - Beudamed, Corning® Glucose Solution (Euro-Collins) | Corning
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K884609 | Class II | Active |
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Manufacturer
- Manufacturer
- Fresenius Usa, Inc.
Sources (1)
- FDA 510(k) K884609 24 fields · synced Sep 26, 2026