# K120881: Mantaray Guidewires

- Pathway: 510(k) (Special)
- Applicant: Bridgepoint Medical
- Decided: Apr 18, 2012 after 26 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: 1 generation back to K111488 (2011). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111488: Mantaray Guidewire Model M-6000, M-6001, M-6002, M-6003, Bridgepoint Medical (2011)

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

## Indications for use
The BridgePoint Medical MantarayTh Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal angioplasty (PTA). The Mantaraym Guidewires are not to be used in the cerebral blood vessels.

Source page: https://510kreport.com/device/K120881
Methodology: https://510kreport.com/methodology