RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING— 510(k) K897137

Name: FDA 510(k) clearance K897137
Creator: U.S. Food and Drug Administration
Published: 1990-03-27

Substantially Equivalent

Research Medical, Inc.

FDA 510(k) clearance K897137 for RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING, Substantially Equivalent on 1990-03-27. Applicant: Research Medical, Inc.. Device class: 2.

Clearance details

Applicant: Research Medical, Inc.
Product code: Code DTL
Device class: Class 2
Regulation: 21 CFR 870.4290
Advisory panel: Cardiovascular
Date received: 1989-12-27
Decision date: 1990-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.