# K022662: Diatek Cannon-Catheter, Model CC5500

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: May 9, 2003 after 273 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 8 (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) Diatek Cannon-Cath: named in the summary without a submission number

## Recalls of this device
- Jun 10, 2008 · Not classified · Z-2250-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2244-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2246-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2251-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2245-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2247-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2248-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2243-2008: The tips may not have been adequately welded to the catheter body.

## Indications for use
The Arrow Diatek™ Cannon Catheter™ is indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. The Cannon Catheter™ is inserted percutaneously and is preferentially placed into the internal jugular vein. Alternately, this catheter may be inserted into subclavian vein, although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Cannon Catheter™ is intended for use in adult patients.

Source page: https://510kreport.com/device/K022662
Methodology: https://510kreport.com/methodology