# K101986: Asahi Ultimatebros 3 Ptca Guide Wire

- Pathway: 510(k) (Special)
- Applicant: Asahi Intecc Co., Ltd.
- Decided: Sep 9, 2011 after 422 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: 9 generations back to K890505 (1989). 16 ancestors in all.
30 later devices descend from it; 3 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022762: Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050, Jomed, Inc. (2002) Summary page 1.
- K031277: Jowire Asahi Ptca Catheter Guide Wires, Models AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002, Jomed, Inc. (2003) Summary page 1.
- K070945: Asahi Ptca Guide Wire, Asahi Intecc Co., Ltd. (2008) Summary page 1.
- K043422: Asahi Ptca Guide Wire, J Shape Series, Asahi Intecc Co., Ltd. (2005) Summary page 1.
- K041531: Asahi Ptca Guide Wire Confianza Pro, Asahi Intecc Co., Ltd. (2004) Summary page 1.
- K032615: Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300, Asahi Intecc Co., Ltd. (2003) Summary page 1.

## Most influential descendants
- K133865: Asahi Gaia First, Second, Third (2014), 29 descendants of its own
- K153106: ASAHI Fielder XT-A, ASAHI Fielder XT-R (2016), 21 descendants of its own
- K163426: ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension (2017), 11 descendants of its own
- K171933: ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter (2018), 7 descendants of its own
- K141339: Asahi RG3 Guidewire/Asahi RG3 Soft Guidewire (2014), 6 descendants of its own

## Indications for use
The ASAHI ULTIMATEbros 3 PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transtuminal angioplasty (PTA). The ASAHI ULTIMATEbros 3 PTCA Guide Wire is not to be used in the cerebral blood vessel.

Source page: https://510kreport.com/device/K101986
Methodology: https://510kreport.com/methodology