# K020012: Modification to Renegade Fiber Braided Microcatheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific/Medi-Tech
- Decided: Jan 29, 2002 after 26 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K073200: Gandras Intravascular Catheter, Models 5580, 5581 and 5582 (2008), 0 descendants of its own

## Recalls of this device
- Aug 26, 2009 · Not classified · Z-2246-2009: 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.

## Indications for use
The Renegade™ Fiber Braided Microcatheters are intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.

Source page: https://510kreport.com/device/K020012
Methodology: https://510kreport.com/methodology