# K141820: Jagwire High Performance Guidwire

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Oct 21, 2014 after 106 days
- Product code: OCY (Endoscopic Guidewire, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Sensor Guidewire: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K960186: Jagwire™ High Performance Guidewire, Jagwire™ High Performance Extendable Guidewire, Jagtail™ High Performance Guidewire Extension. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5.

## Indications for use
Indicated for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts. The guidewires are designed to be used during endoscopic biliary procedures for catheter introduction and exchanges. The Jagtail™ High Performance Guidewire Extension attached to the extendable Jagwire™ 260 cm Guidewire is designed for use during endoscopic biliary procedures for non-rapid exchange catheter introduction and exchanges. The attachment of the Jagtail High Performance Guidewire Extension to the extendable Jagwire 260 cm guidewire creates an extended guidewire that can be used to exchange out a non-rapid exchange biliary catheter without removing the original guidewire from the associated duct. When the exchange is completed, the Jagtail High Performance Guidewire Extension can be detached and the original, extendable Jagwire 260 cm guidewire can be used in a conventional manner.

Source page: https://510kreport.com/device/K141820
Methodology: https://510kreport.com/methodology