TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT— 510(k) K061573

Substantially Equivalent

Hospira, Inc.

FDA 510(k) clearance K061573 for TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT, Substantially Equivalent on 2006-09-19. Applicant: Hospira, Inc..

Clearance details

Applicant: Hospira, Inc.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 2006-06-07
Decision date: 2006-09-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Lake Forest, IL, US

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Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.