# K935997: Platinum Plus Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jun 17, 1994 after 184 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
45 later devices descend from it; 4 cite it directly.
3 of 46 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
- K963702: Acs HI-Torque Iron Man Guide Wire (1997), 36 descendants of its own
- 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

## 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
- Jun 19, 2008 · Not classified · Z-2365-2008: Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene)
- Jun 19, 2008 · Not classified · Z-2364-2008: Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene)
- Jun 19, 2008 · Not classified · Z-2363-2008: Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene)
- Jun 19, 2008 · Not classified · Z-2362-2008: Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene)

Source page: https://510kreport.com/device/K935997
Methodology: https://510kreport.com/methodology