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

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..

Clearance details

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

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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.