# K120533: Bigboss Catheters Mantatay Catheter Mantaray Guidewires

- Pathway: 510(k) (Traditional)
- Applicant: Bridgepoint Medical
- Decided: May 22, 2012 after 90 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- 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: 10 generations back to K931794 (1994). 58 ancestors in all.
5 later devices descend from it; 4 cite it directly.
3 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102725: Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000, Stingray Guidewire Model M-3004 and M, Bridge Medical, Inc. (2011) Summary page 1.
- K113589: Bigboss Catheter, Bridgepoint Medical (2012) Summary page 1.
- K111963: Bridgepoint Medical Mantaray (TM) Catheter, Bridgepoint Medical (2011) Summary page 1.
- K120129: Mantaray Catheter, Bridgepoint Medical (2012) Summary page 1.
- K111488: Mantaray Guidewire Model M-6000, M-6001, M-6002, M-6003, Bridgepoint Medical (2011) Summary page 1.

## Most influential descendants
- 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
- K121745: Mantaray Guidewires (2012), 0 descendants of its own

## Indications for use
The BridgePoint Medical Peripheral System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.

Source page: https://510kreport.com/device/K120533
Methodology: https://510kreport.com/methodology