# K063446: Catheter Repair Kit with Replacement Connector, Model 5587000

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 15, 2006 after 30 days
- Product code: NFK (Kit, Repair, Catheter, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K011015 (2001). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030442: Catheter Repair Kit with Replacement Connector, Model 5587000, C.R. Bard, Inc. (2003) Summary page 2.

## Most influential descendants
- K101261: Catheter Repair Kit with Replacement Connector, Model 5587000 (2010), 0 descendants of its own
- K092797: Acute and Chronic Catheter Repair Kit (2009), 0 descendants of its own

## Indications for use
To replace: Cracked or broken female luer lock connectors or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Soft-Cell* Long-Term Dual Lumen Catheter, Opti-Flow* Long-Tenn Dual Lumen Catheter, Slim-Cath* Short-Term Dual Lumen Catheter, Vaccess* Short-Term Single Lumen Catheter, HemoStar* Long-Term Dual Lumen Catheter, Flexxicon* Short-Term Dual Lumen Catheter, Niagara* Short-Term Dual Lumen Catheter, Flexxicon* 11 Short-Term Dual Lumen Catheter, HemoGlide* Long-Term Dual Lumen Catheter, and HemoSplit* Long-Term Hemodialysis Catheter.

Source page: https://510kreport.com/device/K063446
Methodology: https://510kreport.com/methodology