# K030442: Catheter Repair Kit with Replacement Connector, Model 5587000

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jul 21, 2003 after 160 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: 2 generations back to K011015 (2001). 2 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K022561: Catheter Repair Kit with Replacement Connector, Model 5587000, C.R. Bard, Inc. (2002) Summary page 2.

## Most influential descendants
- K063446: Catheter Repair Kit with Replacement Connector, Model 5587000 (2006), 2 descendants of its own
- 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-Term Dual Lumen CMieter, Slirn-CatliTM Short-Term Dual Lumen Catheter, VaccessB Short-Term Single Lumen Catheter, Flexxicon@ Short-Term Dual Lumen Catheter, NiagaraTM Short-Term Dual Lumen Catheter, Flexxicon@11 Short-Term Dual Lumen Catheter, HemoGlideTh' Long-Term Dual Lumen Catheter, and HemoSplitTM Long-Term Hemodialysis Catheter.

Source page: https://510kreport.com/device/K030442
Methodology: https://510kreport.com/methodology