MEDROYAL ANGIOGRAPHIC CONTROL SYRINGE— 510(k) K920135

Substantially Equivalent

Medroyal, Inc.

FDA 510(k) clearance K920135 for MEDROYAL ANGIOGRAPHIC CONTROL SYRINGE, Substantially Equivalent on 1992-07-24. Applicant: Medroyal, Inc..

Clearance details

Applicant: Medroyal, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1992-01-13
Decision date: 1992-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Powell, TN, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.