CHIN-FOGARTY INFLATION DEVICE— 510(k) K863596

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K863596 for CHIN-FOGARTY INFLATION DEVICE, Substantially Equivalent on 1986-11-20. Applicant: American Edwards Laboratories.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1986-09-15
Decision date: 1986-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.