# K032146: PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires

- Pathway: 510(k) (Abbreviated)
- Applicant: Precision Vascular Systems, Inc.
- Decided: Aug 12, 2003 after 29 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002212 (2000). 1 ancestor in all.
28 later devices descend from it; 4 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002212: Mirage Hydrophilic Guidewire, Model 103-0608, Micro Therapeutics, Inc. (2000) Summary page 1.

## Most influential descendants
- K173235: Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile (2018), 16 descendants of its own
- K183608: Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile (2019), 13 descendants of its own
- K192783: Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile (2019), 12 descendants of its own
- K050964: PV 1900 Synchro 0.016 Guidewire (2005), 10 descendants of its own
- K053268: PVS 2000 SYNCHRO2 Guidewire (2006), 9 descendants of its own

## Recalls of this device
- Apr 18, 2024 · Class II · Z-1939-2024: Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optiona

## Indications for use
The PVS 1300 Synchro@ 0.014" & PVS 1600 Synchro@0.010" Guidewire series of products are intended for general intravascular use, including the neuro and peripheral vasculature. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Source page: https://510kreport.com/device/K032146
Methodology: https://510kreport.com/methodology