# K914531: Stainless Steel Gen Pur Interventional Guide Wires

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Feb 27, 1992 after 139 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
104 later devices descend from it; 1 cites it directly.
7 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K963320: TFX Medical Guidewire (1996), 103 descendants of its own
- K012083: Attain Access 6218 Left-Heart Delivery System, Model 6218 (2001), 89 descendants of its own
- K013517: 10600 Deflectable Catheter System, Model 10600 (2002), 80 descendants of its own
- K032312: Attain 6226DEF Deflectable Catheter Delivery System (2003), 37 descendants of its own
- K033989: Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 (2004), 35 descendants of its own

## Recalls of this device
- Jul 26, 2024 · Class II · Z-3299-2024: Reports have been received regarding open seals on the packaging.

Source page: https://510kreport.com/device/K914531
Methodology: https://510kreport.com/methodology