# K040078: Cannon II Plus

- Pathway: 510(k) (Special)
- Applicant: Arrow International, Inc.
- Decided: Feb 13, 2004 after 30 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 19 (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.
13 later devices descend from it; 2 cite it directly.
3 of 15 devices in its family (counting itself) have 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
- K092205: Palindrome P Hemodialysis Catheter (2009), 11 descendants of its own
- K111372: Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual Lumen Catheter, Palindrome (TM)... (2011), 10 descendants of its own
- K112477: Palindrome H, SI, Hsi Chronic Catheter (2011), 5 descendants of its own
- K123196: Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter, Palindrome Precision Hsi Chronic Cath (2013), 4 descendants of its own
- K140884: Symetrex Long Term Hemodialysis Catheter (2014), 3 descendants of its own

## Recalls of this device
- Jun 10, 2008 · Not classified · Z-2267-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2264-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2253-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2257-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2258-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2263-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2262-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2256-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2261-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2255-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2268-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2254-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2269-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2259-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2270-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2266-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2252-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2265-2008: The tips may not have been adequately welded to the catheter body.
- Jun 10, 2008 · Not classified · Z-2260-2008: The tips may not have been adequately welded to the catheter body.

## Indications for use
The Arrow CannonTM IIPlus is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Cannon TM II Plus is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The CannonTM II Plus is intended for use in adult patients.

Source page: https://510kreport.com/device/K040078
Methodology: https://510kreport.com/methodology