CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT— 510(k) K011217

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K011217 for CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT, Substantially Equivalent on 2001-05-16. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2001-04-20
Decision date: 2001-05-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Abbott Park, IL, US

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Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.