K853136

Substantially Equivalent

MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)

Applicant: E.A. Fischione Instrument Mfg.
Product 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

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.