FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211— 510(k) K960965

Substantially Equivalent

Coeur Laboratories, Inc.

FDA 510(k) clearance K960965 for FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211, Substantially Equivalent on 1996-09-12. Applicant: Coeur Laboratories, Inc..

Clearance details

Applicant: Coeur Laboratories, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1996-03-11
Decision date: 1996-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.