# K963702: Acs HI-Torque Iron Man Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Cardiovascular Systems, Inc.
- Decided: Jan 22, 1997 after 128 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 K935997 (1994). 3 ancestors in all.
36 later devices descend from it; 2 cite it directly.
3 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942066: Acs HI-Torque Extra S'port Guide Wire, Advanced Cardiovascular Systems, Inc. (1994) Summary page 2.
- K950156: Acs HI-Torque Extra S'port (TM) Guide Wire, Advanced Cardiovascular Systems, Inc. (1995) Summary page 2.
- K935997: Platinum Plus Guidewire, Boston Scientific Corp (1994) Summary page 3.

## Most influential descendants
- K982876: HI-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281, 1003282 (1998), 34 descendants of its own
- K061984: Treasure (2006), 32 descendants of its own
- K071721: Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371 (2007), 27 descendants of its own
- K103057: Asahi Astato XS 20 Peripheral Guide Wire (2010), 21 descendants of its own
- K083146: Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000 (2008), 17 descendants of its own

## Indications for use
The HI-TORQUE IRON MAN™ Guide Wire is a steerable guide wire intended to facilitate placement of balloon dilatation catheters during Percutaneous Transluminal Coronary Angioplasty (PTCA) and Percutaneous Transluminal Angioplasty (PTA). The wire is also intended to facilitate the placement of equipment, such as atherectomy and compatible stent devices, during other diagnostic and therapeutic intravascular procedures. It is not intended for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K963702
Methodology: https://510kreport.com/methodology