RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE— 510(k) K945931

Name: FDA 510(k) clearance K945931
Creator: U.S. Food and Drug Administration
Published: 1995-03-03

Substantially Equivalent

Research Industries Corp.

FDA 510(k) clearance K945931 for RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE, Substantially Equivalent on 1995-03-03. Applicant: Research Industries Corp.. Device class: 2.

Clearance details

Applicant: Research Industries Corp.
Product code: Code DTL
Device class: Class 2
Regulation: 21 CFR 870.4290
Advisory panel: Cardiovascular
Date received: 1994-12-05
Decision date: 1995-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midvale, 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.