# K023700: PVS 1600 Synchro 0.010 Neuro Guide Wire

- Pathway: 510(k) (Special)
- Applicant: Precision Vascular Systems, Inc.
- Decided: Dec 4, 2002 after 30 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 K964611 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002907: PVS 1300 Neuro Guide Wire, Precision Vascular Systems, Inc. (2001) Summary page 1.
- K964611: Transend Guidewire, Boston Scientific Corp (1997) Summary page 1.
- K991646: Agility Steerable Guidewire, Cordis Neurovascular, Inc. (1999) Summary page 1.
- K002212: Mirage Hydrophilic Guidewire, Model 103-0608, Micro Therapeutics, Inc. (2000) Summary page 1.
- (no number) PVS 1300 Synchro: named in the summary without a submission number

## Recalls of this device
- Apr 23, 2024 · Class II · Z-1909-2024: Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exc

## Indications for use
The PVS 1600 Synchro@ 0.010" Neuro Guidewire series of products is intended for neurovascular use. It can be used to selectively introduce and position catheters and other interventional devices within the neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Source page: https://510kreport.com/device/K023700
Methodology: https://510kreport.com/methodology