# K111117: Cannon II Plus Chronic Hemodialysis Catheter, Edge Chronic Hemodialysis Catheter, Nextstep (R) Retrograde Chronic...

- Pathway: 510(k) (Special)
- Applicant: Teleflexmedical, Inc.
- Decided: Jun 30, 2011 after 70 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 4 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
3 of 4 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
- K111900: Nextstep Antegrade Chronic Hemodialysis Catheter (2011), 2 descendants of its own
- K130192: Nextstep Retrograde (2013), 1 descendant of its own
- K141051: Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis Catheter, Retrograde Replacement HU (2014), 0 descendants of its own

## Recalls of this device
- Apr 10, 2026 · Class I · Z-2159-2026: 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdr
- Apr 10, 2026 · Class I · Z-2156-2026: 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdr
- Apr 10, 2026 · Class I · Z-2158-2026: 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdr
- Feb 4, 2013 · Class II · Z-1007-2015: The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit.

Source page: https://510kreport.com/device/K111117
Methodology: https://510kreport.com/methodology