REMOVE LABELING RESTRICT FROM GUIDE WIRES— 510(k) K912293

Substantially Equivalent

Target Therapeutics

FDA 510(k) clearance K912293 for REMOVE LABELING RESTRICT FROM GUIDE WIRES, Substantially Equivalent on 1991-12-05. Applicant: Target Therapeutics.

Clearance details

Applicant: Target Therapeutics
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1991-05-23
Decision date: 1991-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, 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.