MALLEABLE SHAFT CLAMP— 510(k) K011078

Substantially Equivalent

Allegiance Healthcare Corp.

FDA 510(k) clearance K011078 for MALLEABLE SHAFT CLAMP, Substantially Equivalent on 2001-07-13. Applicant: Allegiance Healthcare Corp..

Clearance details

Applicant: Allegiance Healthcare Corp.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2001-04-09
Decision date: 2001-07-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Mcgraw Park, IL, US

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Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.