# K101261: Catheter Repair Kit with Replacement Connector, Model 5587000

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jul 29, 2010 after 85 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: 4 generations back to K011015 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063446: Catheter Repair Kit with Replacement Connector, Model 5587000, C.R. Bard, Inc. (2006) Summary page 2.

## Indications for use
To replace: Cracked or bmken female Luer-lock connector or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Equistream Long-Term Dual Lumnen Catheter,

Source page: https://510kreport.com/device/K101261
Methodology: https://510kreport.com/methodology