# K000177: Renegade HI-Flo Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Apr 7, 2000 after 78 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
72 later devices descend from it; 8 cite it directly.
0 of 73 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
- K030637: Ekos Peripheral Infusion System (2003), 50 descendants of its own
- K033214: Ekos Peripheral Infusion System (2003), 46 descendants of its own
- K041629: Lysus Infusion System (2004), 39 descendants of its own
- K042456: Lysus Infusion System (2004), 38 descendants of its own
- K051319: Lysus Infusion System (2005), 35 descendants of its own

## Recalls of this device
- Aug 26, 2009 · Not classified · Z-2245-2009: Boston Scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. It has been reported that the pouch seal (top seal) may be breached.
- Aug 26, 2009 · Not classified · Z-2244-2009: Boston Scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. It has been reported that the pouch seal (top seal) may be breached.
- Aug 24, 2009 · Not classified · Z-0357-2011: Sterility Loss-- The sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection.
- Sep 10, 2007 · Not classified · Z-0109-2008: Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire.
- Aug 10, 2005 · Not classified · Z-0122-2007: Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04

Source page: https://510kreport.com/device/K000177
Methodology: https://510kreport.com/methodology