K971504

Substantially Equivalent

HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER

Applicant: J-Lloyd Medical, Inc.
Product code: DRF
Advisory panel: Cardiovascular
Date received: 1997-04-25
Decision date: 1998-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Berlin, NJ, US

Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.