CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip— 510(k) K170431

Substantially Equivalent

Coeur, Inc.

FDA 510(k) clearance K170431 for CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip, Substantially Equivalent on 2017-08-18. Applicant: Coeur, Inc..

Clearance details

Applicant: Coeur, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2017-02-13
Decision date: 2017-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lebanon, TN, US

Download summary PDF View on FDA.gov ↗

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.