DeviceClearance

SWAN-GANZ FLOW-DIRECTED THERMODILUTION— 510(k) K810352

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K810352 for SWAN-GANZ FLOW-DIRECTED THERMODILUTION, Substantially Equivalent on 1981-03-27. Applicant: American Edwards Laboratories. Device class: 2.

Clearance details

Applicant
American Edwards Laboratories
Product code
Code DYG
Device class
Class 2
Regulation
21 CFR 870.1240
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K810352

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K810352.

Data sourced from openFDA. This site is unofficial and independent of the FDA.