510(k) K893680— SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.

Substantially Equivalent

Cathlab Corp.

Clearance details

Applicant: Cathlab Corp.
Product code: Code DXE
Advisory panel: Cardiovascular
Date received: 1989-05-16
Decision date: 1989-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

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.