TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE— 510(k) K894084

Substantially Equivalent

Target Therapeutics

FDA 510(k) clearance K894084 for TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE, Substantially Equivalent on 1989-08-17. Applicant: Target Therapeutics.

Clearance details

Applicant: Target Therapeutics
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 1989-06-08
Decision date: 1989-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.