# K861563: Vitaguard Percutaneous Infection Control Kit

- Pathway: 510(k) (Traditional)
- Applicant: Vitaphore Corp.
- Decided: Aug 27, 1986 after 124 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
2 of 13 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
- K060972: Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve (Palindrome Ruby) (2006), 7 descendants of its own
- K062671: 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire) (2006), 6 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

Source page: https://510kreport.com/device/K861563
Methodology: https://510kreport.com/methodology