PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES— 510(k) K032146

Name: FDA 510(k) clearance K032146
Creator: U.S. Food and Drug Administration
Published: 2003-08-12

Substantially Equivalent

Precision Vascular Systems, Inc.

FDA 510(k) clearance K032146 for PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES, Substantially Equivalent on 2003-08-12. Applicant: Precision Vascular Systems, Inc.. Device class: 2.

Clearance details

Applicant: Precision Vascular Systems, Inc.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2003-07-14
Decision date: 2003-08-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: West Valley City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQX

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K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 0352026-09-03
K253667 — Accoat Guide Wire2026-07-14
K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire2026-07-13
K254137 — InQwire Amplatz Guide Wire2026-05-22
K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

More clearances from Precision Vascular Systems, Inc.

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K032494 — PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER2003-09-05
K023700 — PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE2002-12-04
K020733 — PVS 1500 SDS2002-03-21
K002907 — PVS 1300 NEURO GUIDE WIRE2001-03-08
K002707 — PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING2000-11-08

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K032146

K-number listed on FDA's recall record

Z-1939-2024 — The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.010in. The outside diameter of the Syncrho 14 guidewire is 0.014in. The guidewires are compatible with existing microcatheters used in common procedures such as those used in endovascular diagnosis and therapy of neurovascular disease. The distal portion of the guidewire tip is radiopaque. For lubricity, the distal portion of the device is coated with a hydrophilic polymer and the proximal portion of the guidewire is coated with polytetrafluoroethylene (PTFE). The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of this device facilitates guidewire placement into the appropriate vessel by precise directional manipulation of the guidewire tip. The introducer included with the guidewire is intended to aid insertion of the guidewire into the catheter hub and/or hemostasis valve.Class II·Ongoing·Stryker Neurovascular·20240418

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032146.

Data sourced from openFDA. This site is unofficial and independent of the FDA.