HIGH PRESSURE FLEX. CONNECTING TUBING— 510(k) K841092

Substantially Equivalent

Tronomed, Inc.

FDA 510(k) clearance K841092 for HIGH PRESSURE FLEX. CONNECTING TUBING, Substantially Equivalent on 1985-07-24. Applicant: Tronomed, Inc..

Clearance details

Applicant: Tronomed, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1984-03-13
Decision date: 1985-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.