510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Coeur, Inc.

Lebanon, TN, US

Coeur, Inc. appears in FDA device records in Lebanon, TN. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
14
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 14 510(k) clearances for Coeur, Inc. between 2005 and 2017. The busiest year on record is 2007, with 3. The most recent is 2017, with 1.

Clearances by year, as a table
510(k) clearance decisions for Coeur, Inc., by decision year
YearClearances
20051
20073
20091
20122
20131
20142
20152
20161
20171
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K170431CT 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 TipDXTSubstantially Equivalent
K161471MR Syringe Dual Pack for Solaris InjectorsDXTSubstantially Equivalent
K150902330psi Extension Y-Line with Dual Check ValveDXTSubstantially Equivalent
K142745125mL CT SyringeDXTSubstantially Equivalent
K140469MR SYRINGE DUAL PACKDXTSubstantially Equivalent
K133600COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTORDXTSubstantially Equivalent
K120892DISPOSABLE 330PSI EXTENSION LINESDXTSubstantially Equivalent
K113498DISPOSABLE TORQUE DEVICEDQXSubstantially Equivalent
K113132DISPOSABLE HEMOSTATIC Y-CONNECTORSDTLSubstantially Equivalent
K090487DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150DXTSubstantially Equivalent
K070798ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORSDXTSubstantially Equivalent
K071196DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERSDQOSubstantially Equivalent
K063114DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVESFPKSubstantially Equivalent
K051799DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORSDXTSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain