# K033321: Selectiva SB Guidewire

- Pathway: 510(k) (Special)
- Applicant: Neometrics, Inc.
- Decided: Nov 5, 2003 after 21 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
Longest line of descent: 2 generations back to K011084 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013024: Selectiva Guidewire, Neometrics, Inc. (2001)
- K943390: Flexfinder Guidewire, Flexmedics (1995) Summary page 1.

## Most influential descendants
- K110739: Entellus Medical Sinus Guidewire (2011), 0 descendants of its own

## Indications for use
The NeoMetrics Selectiva SB Guidewire is intended to facilitate the placement of devices for diagnostic and interventional procedures. NOTE: These guidewires are not intended for PTCA use.

Source page: https://510kreport.com/device/K033321
Methodology: https://510kreport.com/methodology