# K081187: Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001

- Pathway: 510(k) (Traditional)
- Applicant: Bridgepoint Medical
- Decided: Oct 8, 2008 after 163 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: 6 generations back to K890505 (1989). 11 ancestors in all.
13 later devices descend from it; 3 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)
- K970376: Ptca Guidewire, Lake Region Mfg., Inc. (1997) Summary page 1.
- K073082: CPS Courier Guidewire, Brivant, Ltd. (2008) Summary page 1.
- K041531: Asahi Ptca Guide Wire Confianza Pro, Asahi Intecc Co., Ltd. (2004) Summary page 1.

## Most influential descendants
- K083727: Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012 (2009), 12 descendants of its own
- 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

## Indications for use
The BridgePoint Medical Entera guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PCTA) and percutaneous transluminal angioplasty (PTA). The Entera guidewires are not to be used in cerebral blood vessels.

Source page: https://510kreport.com/device/K081187
Methodology: https://510kreport.com/methodology