# K023681: Renegade STC 18 Microcatheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Nov 26, 2002 after 25 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.
7 later devices descend from it; 3 cite it directly.
2 of 8 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 its predicate without a number.
- (no number) Renegade Hi-Flo Microcatheter: named in the summary without a submission number
- (no number) Renegade Fiber Braided Microcatheter: named in the summary without a submission number
- (no number) Excelsior 1018 Microcatheter: named in the summary without a submission number
- (no number) Tracker Excel 14: named in the summary without a submission number

## Most influential descendants
- K121694: Imager II Angiographic Catheter (2012), 2 descendants of its own
- K112124: Microcatheter (2011), 2 descendants of its own
- K133130: Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter (2015), 1 descendant of its own
- K161822: Torcon NB Advantage Catheters (2016), 0 descendants of its own
- K121954: Nmi Microcatheter (2012), 0 descendants of its own

## Recalls of this device
- 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.

## Indications for use
The Renegade STCTM 18 Microcatheter is 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/K023681
Methodology: https://510kreport.com/methodology
