# K113589: Bigboss Catheter

- Pathway: 510(k) (Special)
- Applicant: Bridgepoint Medical
- Decided: Jan 4, 2012 after 30 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001992 (2000). 11 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081130: Bridgepoint Medical Crossboss Percutaneous Coronary Catheter, Bridgepoint Medical (2009) Summary page 1.
- K091841: Bridgepoint Medical Crossboss Catheter, Model M-2000, Bridgepoint Medical (2009) Summary page 1.

## Most influential descendants
- K120533: Bigboss Catheters Mantatay Catheter Mantaray Guidewires (2012), 5 descendants of its own
- K193596: Wingman 14, Wingman 14C, Wingman 18, Wingman 35 (2020), 1 descendant of its own
- K262013: Kiba CTO Crossing Catheter (2026), 0 descendants of its own
- K221163: Tunnel Crossing Catheter (2023), 0 descendants of its own
- K183357: XableCath Crossing Catheter (2019), 0 descendants of its own

## Indications for use
The BridgePoint Medical BigBossTM Catheter is intended to be used in conjunction with a guidewire in order to access discrete regions of the peripheral vasculature. It may be used to facilitate placement of guidewires and other interventional devices.

Source page: https://510kreport.com/device/K113589
Methodology: https://510kreport.com/methodology