USCI PRESTO DISPOSABLE INFLATION DEVICE— 510(k) K896415

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K896415 for USCI PRESTO DISPOSABLE INFLATION DEVICE, Substantially Equivalent on 1990-01-19. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1989-11-08
Decision date: 1990-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, 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.