# K093515: 3 Piece Parodi Guidewire System ( Long Cut Outer with Long Taper .014) Short Taper, 2 Piece Parodi Guidewire System (Lon

- Pathway: 510(k) (Traditional)
- Applicant: Brivant, Ltd.
- Decided: Feb 16, 2010 after 95 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: 6 generations back to K970376 (1997). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060551: Brivant Guidewire, Brivant Limited (2006) Summary page 1.
- K953533: Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil, Terumo Medical Corp. (1995) Summary page 1.
- K944959: Amplatz Super Stiff Guidewire, Boston Scientific Corp (1994) Summary page 1.

## Indications for use
The Parodi Guidewire is designed to direct a catheter to the desired anatomical location during diagnostic or interventional procedures.

Source page: https://510kreport.com/device/K093515
Methodology: https://510kreport.com/methodology