# K121745: Mantaray Guidewires

- Pathway: 510(k) (Special)
- Applicant: Bridgepoint Medical
- Decided: Jul 13, 2012 after 29 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931794 (1994). 60 ancestors in all.
No later device cites it as a predicate yet.
3 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120881: Mantaray Guidewires, Bridgepoint Medical (2012) Summary page 1.
- K120533: Bigboss Catheters Mantatay Catheter Mantaray Guidewires, Bridgepoint Medical (2012) Summary page 1.

## 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/K121745
Methodology: https://510kreport.com/methodology