SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER— 510(k) K910429

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K910429 for SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER, Substantially Equivalent on 1991-07-11. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code DXO
Advisory panel: Cardiovascular
Date received: 1991-02-01
Decision date: 1991-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

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.