PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY— 510(k) K123067

Name: FDA 510(k) clearance K123067
Creator: U.S. Food and Drug Administration
Published: 2013-01-29

Substantially Equivalent

Abbott Vascular, Inc.

FDA 510(k) clearance K123067 for PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY, Substantially Equivalent on 2013-01-29. Applicant: Abbott Vascular, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Vascular, Inc.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2012-10-01
Decision date: 2013-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

Download summary PDF View on FDA.gov ↗

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K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

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K101648 — HI-TORQUE WINN GUIDE WIRE FAMILY2010-07-08
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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 →

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