PHYSIO-PROBE-HIGH PERMEABILITY CATH.— 510(k) K833433

Substantially Equivalent

Research Industries Corp.

FDA 510(k) clearance K833433 for PHYSIO-PROBE-HIGH PERMEABILITY CATH., Substantially Equivalent on 1983-12-29. Applicant: Research Industries Corp..

Clearance details

Applicant: Research Industries Corp.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 1983-10-05
Decision date: 1983-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.