Niagara, Niagara Slim-Cath, and Brevia Short-term Curved Extension Hemodialysis Catheters
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K090102 FDA 510(k)
- FDA Product Code
- MPB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5540 FDA 510(k)
- Regulation Number
- 876.5540 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SEKD FDA 510(k)
The Niagara, Niagara Slim-Cath, and Brevia Short-term Curved Extension Hemodialysis Catheters are specialized catheters designed for temporary vascular access for hemodialysis, apheresis, and hemoperfusion therapy. These catheters are intended for short-term use (less than 30 days) and are inserted via the jugular, subclavian, or femoral vein to establish vascular access.
The catheters are supplied as single-use devices and are classified as Class II medical devices under special controls. They are manufactured by C.R. Bard, Inc. and have received FDA 510(k) clearance with product code MPB. The devices are stored according to the manufacturer's instructions and are not indicated for MRI use.
Frequently asked questions
What are the Niagara, Niagara Slim-Cath, and Brevia Short-term Curved Extension Hemodialysis Catheters used for?
These specialized catheters are designed for temporary vascular access for hemodialysis, apheresis, and hemoperfusion therapy. They are intended for short-term use (less than 30 days) and are inserted via the jugular, subclavian, or femoral vein to establish vascular access.
How are these catheters supplied and can they be reused?
The Niagara, Niagara Slim-Cath, and Brevia catheters are supplied as single-use devices only. They are classified as Class II medical devices under special controls and should not be reused for patient safety and regulatory compliance reasons.
What are the storage requirements for these hemodialysis catheters?
The catheters should be stored according to the manufacturer's instructions. While specific storage conditions aren't detailed in the provided information, it's standard practice to store medical devices in their original packaging in a clean, dry environment at room temperature unless otherwise specified by the manufacturer.
Are these catheters suitable for MRI use?
No, these catheters are not indicated for MRI use. The device information specifically states they are not intended for MRI procedures, which is an important consideration for patients who may require imaging studies during their treatment course.
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: Niagara, Niagara Slim-cath, and Brevia Short-term Curved Extension ..., Niagara™ / Niagara™ Slim-Cath™ Short Term Dialysis Catheter - BD, K090102 - NIAGARA | FDA 510 (k) | C.R. Bard, Inc., Niagara Slim-Cath & Brevia Catheters - C.R. Bard | FDA Reference
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090102 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K090102 24 fields · synced Sep 26, 2026