PVS 2000 SYNCHRO2 GUIDEWIRE— 510(k) K053268

Clearance details

Applicant

Boston Scientific - Precision Vascular

Product code

Code DQX

Device class

Class 2

Regulation

21 CFR 870.1330

Advisory panel

Cardiovascular

Date received

2005-11-23

Decision date

2006-03-13

Decision

Substantially Equivalent

Clearance type

Special

Location

West Valley City, UT, US

• 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

• K050964 — PV 1900 SYNCHRO 0.016 GUIDEWIRE2005-06-13
• K050630 — PIVOT STEERABLE MICROCATHETER2005-03-22

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 →

• Z-1941-2024 — The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. 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.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 K053268.