# K971322: Core and Coil Assembly Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Lake Region Mfg., Inc.
- Decided: Jul 22, 1998 after 468 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.
66 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Flexmedics guidewires: named in the summary without a submission number

## 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
- K012861: Vascupuncture Access Wire (2002), 13 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

## Indications for use
For percutaneous entry of peripheral vessel using the Seldinger technique,

Source page: https://510kreport.com/device/K971322
Methodology: https://510kreport.com/methodology