INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER— 510(k) K924737

Substantially Equivalent

Becton Dickinson Vascular Access, Inc.

FDA 510(k) clearance K924737 for INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER, Substantially Equivalent on 1993-08-23. Applicant: Becton Dickinson Vascular Access, Inc..

Clearance details

Applicant: Becton Dickinson Vascular Access, Inc.
Product code: Code DXO
Advisory panel: Cardiovascular
Date received: 1992-09-22
Decision date: 1993-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sandy, UT, US

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Adverse events under product code DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

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.