FOGARTY 6MM SOFTJAW CLIP— 510(k) K832554

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K832554 for FOGARTY 6MM SOFTJAW CLIP, Substantially Equivalent on 1983-09-29. Applicant: American Edwards Laboratories.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 1983-08-01
Decision date: 1983-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.