REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER— 510(k) K894681

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K894681 for REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER, Substantially Equivalent on 1989-10-12. Applicant: Shiley, Inc..

Clearance details

Applicant: Shiley, Inc.
Product code: Code DXE
Advisory panel: Cardiovascular
Date received: 1989-07-25
Decision date: 1989-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

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.