PERCUTANEOUS INTRODUCER KIT— 510(k) K831636

Substantially Equivalent

Accu-Line

FDA 510(k) clearance K831636 for PERCUTANEOUS INTRODUCER KIT, Substantially Equivalent on 1983-08-24. Applicant: Accu-Line.

Clearance details

Applicant: Accu-Line
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 1983-05-23
Decision date: 1983-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.