# K020430: Diatek Connector Assembly Replacement Kit (Cark)

- Pathway: 510(k) (Traditional)
- Applicant: Diatek, Inc.
- Decided: May 9, 2002 after 90 days
- Product code: NFK (Kit, Repair, Catheter, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010399 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010399: Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC (32 CM), CC3200PC (36 CM), Diatek, Inc. (2001) Summary page 1.

## Most influential descendants
- K141051: Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis Catheter, Retrograde Replacement HU (2014), 0 descendants of its own

## Recalls of this device
- Jul 6, 2020 · Class II · Z-2802-2020: The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other co
- Jul 6, 2020 · Class II · Z-2804-2020: The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other co

## Indications for use
The Diatek Connector Assembly Replacement Kit is to be used for replacing the original connector assembly on a Diatek Cannon-Cath Dialysis Catheter if the connector assembly becomes damaged or dysfunctional. This prevents the patient from requiring additional surgery for catheter removal and replacement. The Connector Assembly Replacement Kit is intended for use in any patient who has a previously implanted Diatek Cannon-Cath Dialysis Catheter implanted.

Source page: https://510kreport.com/device/K020430
Methodology: https://510kreport.com/methodology