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

Clearance details

Applicant

Coeur, Inc.

Product code

Code DQO

Device class

Class 2

Regulation

21 CFR 870.1200

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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• K170431 — 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 Tip2017-08-18
• K161471 — MR Syringe Dual Pack for Solaris Injectors2016-10-06
• K150902 — 330psi Extension Y-Line with Dual Check Valve2015-10-22
• K142745 — 125mL CT Syringe2015-04-01
• K140469 — MR SYRINGE DUAL PACK2014-07-28

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 →