MOVABLE CORE SAFETY GUIDE— 510(k) K790258

Substantially Equivalent

Cordis Corp.

FDA 510(k) clearance K790258 for MOVABLE CORE SAFETY GUIDE, Substantially Equivalent on 1979-02-23. Applicant: Cordis Corp..

Clearance details

Applicant
Cordis Corp.
Product code
Code DQX
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DQX

product code DQX
Death
298
Injury
4,385
Malfunction
7,203
Other
5
Total
11,891

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.