# K051584: 14.5 FR Chronic Hemodialysis Catheter with Insertion Stylets Accessory

- Pathway: 510(k) (Special)
- Applicant: Kendall
- Decided: Oct 6, 2005 after 113 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Maxid 14.5 Fr Chronic Hemodialysis Catheter: named in the summary without a submission number
- (no number) Palindrome 14.5 Fr Chronic Hemodialysis Catheter: named in the summary without a submission number

## Recalls of this device
- Sep 19, 2008 · Not classified · Z-0408-2009: Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.
- Sep 19, 2008 · Not classified · Z-0409-2009: Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.
- Sep 19, 2008 · Not classified · Z-0411-2009: Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.
- Sep 19, 2008 · Not classified · Z-0410-2009: Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.

## Indications for use
The 14.5 Fr Chronic Hemodialysis Catheter with Insertion Stylets is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down.

Source page: https://510kreport.com/device/K051584
Methodology: https://510kreport.com/methodology