# K092797: Acute and Chronic Catheter Repair Kit

- Pathway: 510(k) (Traditional)
- Applicant: Kendall
- Decided: Nov 19, 2009 after 69 days
- Product code: NFK (Kit, Repair, Catheter, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 1 (0 Class I)
- 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 1.

## Recalls of this device
- Apr 29, 2019 · Class II · Z-1955-2019: The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.

## Indications for use
The Covidien Acute and Chronic Catheter Repair Kit is intended to repair the external extension tubing, luer adapter or clamp of a hemodialysis catheter manufactured by Covidien. Do not use this kit to repair a catheter if the damaged portion of the extension tubing is more than 0.5 cm away from the distal end of the luer adapter. Specific hemodialysis catheters that can be repaired using this kit include: · Palindrome TM Chronic Care Catheters * Palindrome TM EmeraldTM Chronic Care Catheters • Palindrome TM RubyTM Chronic Care Catheters * PalindromeTM SapphireTM Chronic Care Catheters * MAHURKAR m * MaxidTM Chronic Care Catheters * MAHURKARTm* 8 Fr. (2.67mm) Single Lumen Acute Care Catheters * MAHURKARTm* 8 Fr. (2.67mm) Dual Lumen Acute Care Catheters MAHURKARTm* 10 Fr. (3.33mm) Dual Lumen Acute Care Catheters * MAHURKARTm* 11.5 Fr. (3:83mm) Dual Lumen Acute Care Catheters * MAHURKARTM* 13.5 Fr. (4.50mm) High Flow Dual Lumen Acute Care Catheters * MAHURKARTM* 12 Fr. (4.00mm) Triple Lumen Acute Care Catheters. (Note: do not use this kit to repair the infusion lumen.)

Source page: https://510kreport.com/device/K092797
Methodology: https://510kreport.com/methodology