K963248

Substantially Equivalent

FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)

Applicant: J-Lloyd Medical, Inc.
Product code: DYG
Advisory panel: Cardiovascular
Date received: 1996-08-19
Decision date: 1997-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Berlin, NJ, US

Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.