# K973645: Renegade Fiber Braided Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Nov 19, 1997 after 56 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 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) Evolution Microcatheter: named in the summary without a submission number
- (no number) Eddy Infusion: named in the summary without a submission number
- (no number) TurboTracker Infusion Catheter: named in the summary without a submission number
- (no number) Venture II Intravascular infusion catheters: named in the summary without a submission number

## Most influential descendants
- K082613: Merit Microcatheter (2008), 7 descendants of its own
- K161921: SwiftNINJA Microcatheter (2016), 4 descendants of its own
- K190126: Bendit2.7 Steerable Microcatheter (2019), 2 descendants of its own
- K200582: Bendit2.7 Steerable Microcatheter (2020), 1 descendant of its own
- K172081: Maestro Microcatheter (2017), 1 descendant of its own

## Recalls of this device
- Aug 24, 2009 · Not classified · Z-0358-2011: 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.
- Oct 13, 2006 · Not classified · Z-0177-2007: Incorrect expiration date: The product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct)

## Indications for use
The Renegade Fiber Braided 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 the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.

Source page: https://510kreport.com/device/K973645
Methodology: https://510kreport.com/methodology