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510(k) Data Aggregation
K Number
K252226Device Name
Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
Manufacturer
Date Cleared
2025-08-13
(28 days)
Product Code
Regulation Number
876.5540Why did this record match?
Product Code :
NQJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K233515Device Name
Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
Manufacturer
Date Cleared
2023-12-26
(55 days)
Regulation Number
876.5540Why did this record match?
Product Code :
NQJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dual Lumen Extended Length Catheter (dELC) is indicated for use up to 72 hours in attaining vascular venous access for use with the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy. It is not for pediatric use. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.
Device Description
The Dual Lumen Extended Length Catheter (dELC) is a 6F reverse-tapered dual lumen venous access device with stainless steel coil reinforcement. It is inserted into peripheral venous circulation by way of a peel away introducer. The catheter is intended for short-term use with the Aquadex FlexFlow® and Aquadex SmartFlow® Systems in attaining vascular venous access for ultrafiltration treatment of patients with fluid overload. It has two models, 320101 and 320102, with identical hub designs but different effective (insertable) shaft lengths, 12 cm and 16 cm, to adapt to the patient's body size. The catheter has a radiopaque polyurethane shaft with two equal-sized inner lumens designed in a "double D" configuration. The shaft has a reverse-tapered design to minimize resistance to flow. Its outside diameter starts at 6F on the distal end and tapers back to 7F on the proximal end. The shaft with reinforcement provides kinking resistance and ensures consistent flow. the Catheter has female ISO 80369-compliance Luer connectors to connect with the Aquadex blood tubing set for withdrawal and infusion. Each extension tube has a clamp: blue on the blood withdrawal tube and white on the blood infusion tube. The blood is drawn up through the withdrawal lumen, which is proximal to the infusion lumen. The skived offset tip is designed to minimize blood recirculation.
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K Number
K041791Device Name
5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
Manufacturer
Date Cleared
2004-09-10
(70 days)
Regulation Number
876.5540Why did this record match?
Product Code :
NQJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 5.2F dELC catheter is a peripheral venous access catheter, inserted preferably in the basilic vein (arm) and antecubital region respectively and specifically for use with the Aquadex™ System 100 when the blood flow rate is set at ≤20ml/minute.
The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.
The Aquadex System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.
Device Description
The 5.2F dELC is a 16 gauge, polyurethane, dual lumen extended-length catheter. It is intended to provide short-term peripheral venous access to facilitate blood removal and return for the purposes of ultrafiltration. The catheter has a low profile, flexible hub with suture wings for securement to the skin. The dual lumen tubing in the proximal portion of the catheter shaft is a double-D configuration and is fused to a single lumen tube for the distal portion. The catheter shaft construction includes a 304 stainless steel coil to minimize kinking from bending. The blood is drawn up through the single lumen tubing, and infused back into the vessel through the short proximal dual lumen section of the catheter shaft. The catheter will connect directly to the UF circuit of the Aquadex System 100 to conduct blood to and from the patient for the purposes of ultrafiltration. The 5.2F dELC is compatible with the Aquadex System 100 which utilizes software allowing blood flow rate adjustment as this catheters' optimal blood flow rate is at ≤20ml/minute.
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K Number
K031689Device Name
DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
Manufacturer
Date Cleared
2003-12-23
(204 days)
Regulation Number
876.5540Why did this record match?
Product Code :
NQJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dual Lumen ELC catheters are peripheral venous access catheters, inserted preferably in the basilic vein (arm) and antecubital region respectively, and specifically for use with the System 100. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs. The System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.
Device Description
The dELC is a 6 French, polyurethane, dual lumen extended-length catheter. It is intended to provide short-term peripheral venous access to facilitate blood removal and return for the purposes of ultrafiltration. The catheter has a low profile, flexible hub with suture wings for securement to the skin. The dual lumen tubing in the proximal portion of the catheter shaft is a double-D configuration and is bonded to a single lumen tube for the distal portion. The blood is drawn up through the single lumen tubing, and infused back into the vessel through the short proximal section of the catheter shaft. The catheter will connect directly to the UF circuit of the System 100 to conduct blood to and from the patient for the purposes of ultrafiltration.
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