# K050964: PV 1900 Synchro 0.016 Guidewire

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific - Precision Vascular
- Decided: Jun 13, 2005 after 56 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002212 (2000). 4 ancestors in all.
10 later devices descend from it; 1 cites 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.
- K971254: Transend EX Platinum Guidewire, Boston Scientific Corp (1997) Summary page 1.
- K913074: 0.016 Guide Wire for Neurological Endoscope, Terumo Medical Corp. (1991) Summary page 1.

## Cited in the summary but kept off the family tree
- K011051: Agility-16. 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

## Most influential descendants
- K053268: PVS 2000 SYNCHRO2 Guidewire (2006), 9 descendants of its own
- 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

## Recalls of this device
- Jun 7, 2010 · Not classified · Z-0878-2011: 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-0879-2011: 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-0876-2011: 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-0877-2011: 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-0881-2011: 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-0880-2011: 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

## Indications for use
The PV 1900 Synchro® 0.016" Guidewire series of products are intended for general intravascular use, including the neuro and peripheral vasculature. It 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/K050964
Methodology: https://510kreport.com/methodology