FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)— 510(k) K963248

Substantially Equivalent

J-Lloyd Medical, Inc.

FDA 510(k) clearance K963248 for FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P), Substantially Equivalent on 1997-02-03. Applicant: J-Lloyd Medical, Inc..

Clearance details

Applicant: J-Lloyd Medical, Inc.
Product code: 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

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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.