# K955637: Essence Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Mar 11, 1996 after 91 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: 1 generation back to K905432 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930982: Illusion Steerable Microguidewire for Neurovac Use, Cordis Corp. (1994) Summary page 1.
- K905432: Datascope Interlock Guide Wire Extension, Datascope Corp. (1991) Summary page 1.
- K914030: Guider, Dasher, Target Therapeutics (1992) Summary page 1.

## Indications for use
The ESSENCE™ Guidewires are intended for the introduction and positioning of catheters and interventional devices within the peripheral, coronary and neurovascular systems. The guidewires have a soft, flexible tip and may be used with intravascular devices what are indicated for use with such guidewires.

Source page: https://510kreport.com/device/K955637
Methodology: https://510kreport.com/methodology