SMALL CATHETER INFLATOR— 510(k) K896005

Substantially Equivalent

Allied Systems Co.

FDA 510(k) clearance K896005 for SMALL CATHETER INFLATOR, Substantially Equivalent on 1990-02-26. Applicant: Allied Systems Co..

Clearance details

Applicant: Allied Systems Co.
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 1989-10-13
Decision date: 1990-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmington, CT, 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.