# K082935: Vision Wire Coronary Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Dec 4, 2008 after 64 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: 5 generations back to K002206 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030019: Modification to HI-Torque Whisper Guidewire, Guidant Corp. (2003) Summary page 1.
- K061453: HI-Torque Whisper View Guide Wire, Guidant Corp. (2006) Summary page 1.
- K964272: Performr Series EP Diagnostic Catheters, Medtronic Cardiorhythm (1997) Summary page 1.

## Indications for use
The VisionWire coronary guide wire is intended for the following applications: · Its positioning in the coronary vascular system (probing coronary vessel anatomy) · Connection to an external pacing system analyzer in order to perform the following intraoperative tests in several places e.g. of the coronary sinus: o Measuring the left ventricular threshold o Measuring the intracardiac signals o Temporary pacing of the left ventricle · As a guide wire for positioning compatible over-the-wire (OTW) pacing leads in the coronary sinus

Source page: https://510kreport.com/device/K082935
Methodology: https://510kreport.com/methodology