FDA 510(k) Applications Submitted by LARAINE PANGELINA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090085 |
01/13/2009 |
MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 |
CONCENTRIC MEDICAL, INC. |
| K090335 |
02/10/2009 |
HD GUIDE CATHETER |
CONCENTRIC MEDICAL, INC. |
| K100454 |
02/17/2010 |
HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V |
MICROVENTION, INC. |
| K080583 |
03/03/2008 |
MODIFIED HD GUIDE CATHETER |
CONCENTRIC MEDICAL, INC. |
| K120908 |
03/26/2012 |
HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
| K111307 |
05/10/2011 |
AZUR DETACHABLE 35 PLATINUM COIL SYSTEM |
MICROVENTION, INC. |
| K961923 |
05/17/1996 |
BERENSTEIN COIL |
TARGET THERAPEUTICS |
| K111451 |
05/25/2011 |
MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX |
MICROVENTION, INC. |
| K962503 |
06/27/1996 |
GUGLIELMI DETACHABLE COIL |
TARGET THERAPEUTICS |
| K131948 |
06/27/2013 |
MICROPLEX COIL SYSTEM (MCS) |
MICROVENTION, INC. |
| K132083 |
07/05/2013 |
AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 |
MICRO VENTION, INC. |
| K082034 |
07/17/2008 |
MODIFICATION TO MERCI RETRIEVER |
CONCENTRIC MEDICAL, INC. |
| K132317 |
07/25/2013 |
MICROPLEX COIL SYSTEM (MCS), VFC |
MICROVENTION, INC. |
| K112226 |
08/03/2011 |
HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
| K042218 |
08/05/2004 |
ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM |
GUIDANT CORP. |
| K102365 |
08/20/2010 |
MICROPLEX COIL SYSTEM- COSMOS |
MICROVENTION, INC. |
| K122543 |
08/21/2012 |
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 |
MICROVENTION, INC. |
| K963307 |
08/22/1996 |
GDC PATIENT RETURN ELECTTRODE MODEL 45021 |
TARGET THERAPEUTICS |
| K162524 |
09/09/2016 |
AZUR CX Detachable 18 Peripheral Coil System |
MicroVention, Inc |
| K132952 |
09/19/2013 |
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
| K003198 |
10/12/2000 |
VULCAN TAC PROBES, MODEL 911XXX |
ORATEC INTERVENTIONS, INC. |
| K964112 |
10/15/1996 |
BERENSTEIN COIL |
TARGET THERAPEUTICS |
| K964210 |
10/22/1996 |
RETRIEVER II |
TARGET THERAPEUTICS |
| K093358 |
10/28/2009 |
MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V |
MICROVENTION, INC. |
| K162999 |
10/28/2016 |
V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System |
MICROVENTION, INC |
| K955293 |
11/16/1995 |
FIBERED PLATINUM COIL, .035 TYPE |
TARGET THERAPEUTICS |
| K113457 |
11/22/2011 |
HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
| K133626 |
11/26/2013 |
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 |
MICROVENTION, INC. |
| K153594 |
12/16/2015 |
MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) |
MICROVENTION, INC. |
| K043500 |
12/20/2004 |
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE |
INNOSPINE, INC. |
| K093919 |
12/22/2009 |
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V |
MICROVENTION, INC. |
| K103758 |
12/23/2010 |
MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 |
MICROVENTION, INC. |
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