# K111963: Bridgepoint Medical Mantaray (TM) Catheter

- Pathway: 510(k) (Special)
- Applicant: Bridgepoint Medical
- Decided: Aug 10, 2011 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: 8 generations back to K931794 (1994). 24 ancestors in all.
7 later devices descend from it; 2 cite it directly.
3 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080987: Bridgepoint Medical Stingray Device and Accessories, Bridgepoint Medical (2009) Summary page 1.
- K101591: Stingray Orienting Balloon Catheter, Bridgepoint Medical (2010) Summary page 1.

## Most influential descendants
- K120129: Mantaray Catheter (2012), 6 descendants of its own
- 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

## Indications for use
The BridgePoint Medical MantarayTM Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the peripheral vasculature.

Source page: https://510kreport.com/device/K111963
Methodology: https://510kreport.com/methodology