# K010399: Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC (32 CM), CC3200PC (36 CM)

- Pathway: 510(k) (Traditional)
- Applicant: Diatek, Inc.
- Decided: Aug 14, 2001 after 186 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- 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
No predicates in its family tree.
21 later devices descend from it; 3 cite it directly.
5 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040078: Cannon II Plus (2004), 13 descendants of its own
- 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
- K040260: Integral Hemodialysis Catheter (2004), 5 descendants of its own

## Recalls of this device
- Jun 10, 2008 · Not classified · Z-2242-2008: The tips may not have been adequately welded to the catheter body.
- Sep 16, 2003 · Not classified · Z-0084-04: wrong product in box

Source page: https://510kreport.com/device/K010399
Methodology: https://510kreport.com/methodology