# K053268: PVS 2000 SYNCHRO2 Guidewire

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific - Precision Vascular
- Decided: Mar 13, 2006 after 110 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002212 (2000). 5 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032146: PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires, Precision Vascular Systems, Inc. (2003) Summary page 1.
- K050964: PV 1900 Synchro 0.016 Guidewire, Boston Scientific - Precision Vascular (2005) Summary page 1.
- K971254: Transend EX Platinum Guidewire, Boston Scientific Corp (1997) Summary page 1.

## Most influential descendants
- K202522: Synchro SELECT Guidewire (2020), 6 descendants of its own
- K243756: 0.014” Willow Guidewire (2025), 4 descendants of its own
- K253168: 0.014” Willow Guidewire (2025), 3 descendants of its own
- K260130: Willow 18 Guidewire (2026), 1 descendant of its own
- K190843: Synchro2 Support Guidewire (2019), 1 descendant of its own

## Recalls of this device
- Apr 18, 2024 · Class II · Z-1941-2024: 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
- Jun 7, 2010 · Not classified · Z-0871-2011: The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system
- Jun 7, 2010 · Not classified · Z-0874-2011: The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system
- Jun 7, 2010 · Not classified · Z-0869-2011: The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system
- Jun 7, 2010 · Not classified · Z-0870-2011: The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system
- Jun 7, 2010 · Not classified · Z-0872-2011: The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system
- Jun 7, 2010 · Not classified · Z-0873-2011: The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system
- Jun 7, 2010 · Not classified · Z-0868-2011: The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system
- Jun 7, 2010 · Not classified · Z-0875-2011: The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system
- Jun 3, 2010 · Not classified · Z-2069-2010: Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic
- Jun 3, 2010 · Not classified · Z-2070-2010: Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic
- Jun 3, 2010 · Not classified · Z-2071-2010: Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic
- Jun 3, 2010 · Not classified · Z-2068-2010: Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic

## Indications for use
The PV 2000 Synchro®2 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/K053268
Methodology: https://510kreport.com/methodology