# K033742: Boston Scientific V-18 Control Wire

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jan 12, 2004 after 45 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 K934359 (1993). 1 ancestor in all.
33 later devices descend from it; 2 cite it directly.
3 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934359: Scimed Strike Steerable Guide Wire, Scimed Peripheral Interventions (1993) Summary page 1.

## Most influential descendants
- 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
- K150445: ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) (2015), 16 descendants of its own

## Indications for use
The 110cm V-18 Control Wire is intended for general intravascular use including the placement of PTA balloon catheters requiring an 0.018" guide wire in hemodialysis AV access procedures. The wire can be torqued to facilitate placement of diagnostic or therapeutic catheters. This device is intended for peripheral vascular use only. A torque device is included with each wire to facilitate directional manipulation of the guide wire.

Source page: https://510kreport.com/device/K033742
Methodology: https://510kreport.com/methodology