# K083727: Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012

- Pathway: 510(k) (Special)
- Applicant: Bridgepoint Medical
- Decided: Feb 20, 2009 after 67 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: 7 generations back to K890505 (1989). 12 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 25 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.
- K041531: Asahi Ptca Guide Wire Confianza Pro, Asahi Intecc Co., Ltd. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K970396: Human Chorionic Gonadotropin Calibrator, Dade Chemistry Systems, Inc. (1997). Our reading of the summary gave K970396, FDA’s number for Human Chorionic Gonadotropin Calibrator (Dade Chemistry Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Triumph PTCA Guidewire”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K102725: Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000, Stingray Guidewire Model M-3004 and M (2011), 11 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
- K152401: Stingray LP Catheter (2015), 1 descendant of its own
- K262013: Kiba CTO Crossing Catheter (2026), 0 descendants of its own

## Indications for use
The BridgePoint Medical StingrayTM 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 Stingraytm Guidewires are notto be used in cerebral blood vessels.

Source page: https://510kreport.com/device/K083727
Methodology: https://510kreport.com/methodology