# K122795: Stingray Guidewires

- Pathway: 510(k) (Special)
- Applicant: Bridgepoint Medical
- Decided: Nov 8, 2012 after 57 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K890505 (1989). 54 ancestors in all.
No later device cites it as a predicate yet.
3 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081187: Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001, Bridgepoint Medical (2008) Summary page 1.
- K083727: Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012, Bridgepoint Medical (2009) Summary page 1.
- 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.

## Recalls of this device
- Dec 19, 2018 · Class II · Z-0852-2019: A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.

## Indications for use
The BridgePoint Medical Stingray Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Stingray Guidewires are not to be used in the cerebral blood vessels. When used as part of the BridgePoint Medical System (consisting of the CrossBoss Catheter, Stingray Catheter, and Stingray Guidewire), the Stingray Guidewire is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention.

Source page: https://510kreport.com/device/K122795
Methodology: https://510kreport.com/methodology