K974335

Substantially Equivalent

EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.

Applicant: J-Lloyd Medical, Inc.
Product code: DXE
Advisory panel: Cardiovascular
Date received: 1997-11-18
Decision date: 1998-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Berlin, NJ, 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.