Catheter Repair Kit With Replacement Connector, Model 5587000
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K022561 FDA 510(k)
- FDA Product Code
- NFK 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
- SESE Substantially Equivalent FDA 510(k)
The Catheter Repair Kit with Replacement Connector, Model 5587000, is a medical device designed for the repair of hemodialysis catheters. It provides the necessary components to facilitate the maintenance and restoration of catheter function.
This kit is regulated under the gastroenterology and urology medical specialties and has received FDA 510k clearance. It is identified by product code NFK and is manufactured by C. R. Bard, Inc.
Frequently asked questions
What is the primary purpose of the Model 5587000 repair kit?
This kit is specifically designed for the repair of hemodialysis catheters. It includes a replacement connector and the necessary components to facilitate the restoration of catheter function.
What is the regulatory status of this device?
The Catheter Repair Kit, Model 5587000, has received FDA 510k clearance. It is classified under the gastroenterology and urology medical specialties and is identified by product code NFK.
Who is the manufacturer of this repair kit?
This device is manufactured by C. R. Bard, Inc., located in Salt Lake City, Utah.
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: Cr Bard Catheter Repair Kits w/Replacement Conne - Catheter Repair Kit ..., GlidePath™ Long-Term Hemodialysis Catheter - 5587000 | BD, How to Insert a Catheter: 11 Steps (with Pictures) - wikiHow, Bard Peripheral Vascular - Repair Kit - 5587000 - Health Med Resources
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K022561 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K022561 24 fields · synced Sep 27, 2026