# K945379: Platinum Plus Guidewire with Hydrophilic Coating

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jun 5, 1995 after 215 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 1 cites it directly.
3 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

## Recalls of this device
- Aug 25, 2008 · Not classified · Z-0030-2009: Boston Scientific is initiating a voluntary recall of the Platinum Plus Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual packaged
- Aug 25, 2008 · Not classified · Z-0031-2009: Boston Scientific is initiating a voluntary recall of the Platinum Plus" Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual package

Source page: https://510kreport.com/device/K945379
Methodology: https://510kreport.com/methodology