FDA 510(k) Applications Submitted by DEBRA MANNING
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090487 |
02/25/2009 |
DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 |
COEUR, INC. |
| K961085 |
03/19/1996 |
DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING |
DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES |
| K961087 |
03/19/1996 |
DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS |
DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES |
| K961097 |
03/19/1996 |
ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES |
DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES |
| K070798 |
03/23/2007 |
ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS |
COEUR, INC. |
| K120892 |
03/23/2012 |
DISPOSABLE 330PSI EXTENSION LINES |
COEUR, INC. |
| K071196 |
04/30/2007 |
DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS |
COEUR, INC. |
| K051799 |
07/05/2005 |
DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS |
COEUR, INC. |
| K032920 |
09/22/2003 |
THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 |
COEUR MEDICAL |
| K063114 |
10/11/2006 |
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES |
COEUR, INC. |
| K954716 |
10/13/1995 |
DEROYAL INDUSTRIES INFANT HEEL WARMER |
DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES |
| K113132 |
10/24/2011 |
DISPOSABLE HEMOSTATIC Y-CONNECTORS |
COEUR, INC. |
| K113498 |
11/25/2011 |
DISPOSABLE TORQUE DEVICE |
COEUR, INC. |
| K133600 |
11/25/2013 |
COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR |
COEUR, INC. |
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