DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS— 510(k) K071196

Substantially Equivalent

Coeur, Inc.

FDA 510(k) clearance K071196 for DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS, Substantially Equivalent on 2007-09-06. Applicant: Coeur, Inc..

Clearance details

Applicant: Coeur, Inc.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2007-04-30
Decision date: 2007-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lebanon, TN, 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.