MODEL 1000 APC-ANGIOPLASTY PRESSURE— 510(k) K841493

Substantially Equivalent

E.A. Fischione Instrument Mfg.

FDA 510(k) clearance K841493 for MODEL 1000 APC-ANGIOPLASTY PRESSURE, Substantially Equivalent on 1984-06-11. Applicant: E.A. Fischione Instrument Mfg..

Clearance details

Applicant: E.A. Fischione Instrument Mfg.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1984-04-10
Decision date: 1984-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.