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Panels › Cardiovascular › Product code NRY · Class 2

Catheter, Thrombus Retriever

Regulation 870.1250

15510(k)s in 12 months (117 all time)

2recalls in 12 months (27 all time)

23recalls that name a 510(k)

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Top companies in NRY

Company	510(k)s	Recalls
Penumbra, Inc.	25	8
Concentric Medical, Inc.	16	2
Stryker Neurovascular	2	11
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	11	0
Imperative Care, Inc.	7	1
Alembic, LLC	7	0
Perfuze, Ltd.	6	0
Rapid Medical Ltd.	6	0
CERENOVUS, Inc.	5	0
Neuravi Limited	5	0

Decided	510(k)	Device and applicant	Code
Oct 31, 2012	K122478	MODIFIED TREVO RETRIEVER Concentric Medical, Inc.	NRY
Aug 3, 2012	K120961	TREVO RETRIEVER Concentric Medical, Inc.	NRY
Mar 2, 2012	K113455	SOLITAIRE FR REVASCULARIZATION DEVICE Micro Therapeutics Dba Ev3 Neurovascular	NRY
Nov 23, 2011	K113163	PENUMBRA SYSTEM MAX Penumbra, Inc.	NRY
Feb 17, 2011	K093610	MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153 Concentric Medical, Inc.	NRY
May 21, 2010	K100769	PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054 Penumbra, Inc.	NRY
Sep 21, 2009	K090752	PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054 Penumbra, Inc.	NRY
Feb 12, 2009	K090085	MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 Concentric Medical, Inc.	NRY
Aug 15, 2008	K082034	MODIFICATION TO MERCI RETRIEVER Concentric Medical, Inc.	NRY
Jun 5, 2008	K081305	MERCI RETRIEVER Concentric Medical, Inc.	NRY
Dec 28, 2007	K072718	PENUMBRA SYSTEM Penumbra, Inc.	NRY
Aug 22, 2007	K071172	MODIFIED MERCI RETRIEVER, MODEL 90060 Concentric Medical, Inc.	NRY
Apr 24, 2007	K070521	MODIFIED MERCY RETRIEVER, MODEL 90070 Concentric Medical, Inc.	NRY
Jan 24, 2007	K063774	MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6 Concentric Medical, Inc.	NRY
Jan 19, 2007	K062046	MODIFIED MERCI RETRIEVER, MODEL 90050 Concentric Medical, Inc.	NRY
May 25, 2006	K061059	MODIFIED MERCI RETRIEVER, MODEL 90092 Concentric Medical, Inc.	NRY
Aug 11, 2004	K033736	MERCI RETRIEVER, MODELS 90065, 90066 Concentric Medical, Inc.	NRY

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