MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)— 510(k) K853136

Substantially Equivalent

E.A. Fischione Instrument Mfg.

FDA 510(k) clearance K853136 for MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER), Substantially Equivalent on 1985-12-03. Applicant: E.A. Fischione Instrument Mfg..

Clearance details

Applicant: E.A. Fischione Instrument Mfg.
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 1985-07-26
Decision date: 1985-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

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Adverse events under product code MAV

product code MAV

Malfunction: 1,433
Total: 1,433

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.