K914828

Substantially Equivalent

010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF

Applicant: Advanced Cardiovascular Systems, Inc.
Product code: DQX
Advisory panel: Cardiovascular
Date received: 1991-10-24
Decision date: 1992-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

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.