RMI ARTERIAL PERFUSION CANNULA— 510(k) K894243

Substantially Equivalent

Research Medical, Inc.

FDA 510(k) clearance K894243 for RMI ARTERIAL PERFUSION CANNULA, Substantially Equivalent on 1989-09-19. Applicant: Research Medical, Inc..

Clearance details

Applicant: Research Medical, Inc.
Product code: Code DQR
Advisory panel: Cardiovascular
Date received: 1989-06-21
Decision date: 1989-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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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.