INTRAFLON, INTRAFLUX, INTRAVALVE— 510(k) K813144

Substantially Equivalent

Exco, Inc.

FDA 510(k) clearance K813144 for INTRAFLON, INTRAFLUX, INTRAVALVE, Substantially Equivalent on 1981-11-27. Applicant: Exco, Inc..

Clearance details

Applicant: Exco, Inc.
Product code: Code DQR
Advisory panel: Cardiovascular
Date received: 1981-11-05
Decision date: 1981-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQR

product code DQR

Death: 2
Total: 2

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.