CATHETER BALLOON DILATOR PRESSURE GAUGE— 510(k) K895511

Substantially Equivalent

Argon Medical Corp.

FDA 510(k) clearance K895511 for CATHETER BALLOON DILATOR PRESSURE GAUGE, Substantially Equivalent on 1990-02-28. Applicant: Argon Medical Corp..

Clearance details

Applicant: Argon Medical Corp.
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 1989-09-12
Decision date: 1990-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, TX, 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.