# K011084: Mandrel Guidewire Assembly

- Pathway: 510(k) (Special)
- Applicant: Lake Region Mfg., Inc.
- Decided: May 10, 2001 after 30 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
No predicates in its family tree.
81 later devices descend from it; 11 cite it directly.
0 of 82 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
- K040010: Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy) Systems (2004), 51 descendants of its own
- K143563: Infusion Aspiration Catheter System (2015), 35 descendants of its own
- K013024: Selectiva Guidewire (2001), 15 descendants of its own
- K031652: Vascupuncture Picc Guidewire (2003), 12 descendants of its own
- K040786: Vascupuncture Picc Guidewire with Hydro-Silk Coating (2004), 11 descendants of its own

Source page: https://510kreport.com/device/K011084
Methodology: https://510kreport.com/methodology