# K002907: PVS 1300 Neuro Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Precision Vascular Systems, Inc.
- Decided: Mar 8, 2001 after 171 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023700: PVS 1600 Synchro 0.010 Neuro Guide Wire (2002), 0 descendants of its own

## 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

Source page: https://510kreport.com/device/K002907
Methodology: https://510kreport.com/methodology