COSGROVE CLAMP— 510(k) K974769

Substantially Equivalent

Allegiance Healthcare Corp.

FDA 510(k) clearance K974769 for COSGROVE CLAMP, Substantially Equivalent on 1998-06-12. Applicant: Allegiance Healthcare Corp.. Device class: 2.

Clearance details

Applicant
Allegiance Healthcare Corp.
Product code
Code DXC
Device class
Class 2
Regulation
21 CFR 870.4450
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mcgraw Park, IL, US
Download summary PDFView on FDA.gov ↗

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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, through . 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.