J-LLOYD ARTERIAL EMBOLECTOMY CATHETER— 510(k) K920871

Substantially Equivalent

J-Lloyd Medical, Inc.

FDA 510(k) clearance K920871 for J-LLOYD ARTERIAL EMBOLECTOMY CATHETER, Substantially Equivalent on 1993-02-26. Applicant: J-Lloyd Medical, Inc..

Clearance details

Applicant: J-Lloyd Medical, Inc.
Product code: Code DXE
Advisory panel: Cardiovascular
Date received: 1992-02-25
Decision date: 1993-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Berlin, NJ, 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.