Arstasis, Inc. is one of 18437 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Arstasis, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MicroTract Access System, AXERA 2 ACCESS SYSTEM, AXERA RX ACCESS SYSTEM
14
Total
14
Cleared
0
Denied
Arstasis, Inc. has 14 FDA 510(k) cleared cardiovascular devices. Based in San Carlos, US.
Historical record: 14 cleared submissions from 2010 to 2015.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Arstasis, Inc.
14 devices
Cleared
Aug 07, 2015
MicroTract Access System
Cardiovascular
29d
Cleared
Jun 06, 2014
AXERA 2 ACCESS SYSTEM
Cardiovascular
63d
Cleared
May 16, 2014
AXERA RX ACCESS SYSTEM
Cardiovascular
100d
Cleared
Mar 28, 2014
AXERA 2 ACCESS SYSTEM
Cardiovascular
60d
Cleared
Aug 19, 2013
AXERA 2 ACCESS SYSTEM
Cardiovascular
28d
Cleared
Mar 24, 2013
AXERA 2 ACCESS SYSTEM
Cardiovascular
121d
Cleared
CT
Jan 28, 2013
AXERA 2 ACCESS SYSTEM MODEL AXE200
Cardiovascular
115d
Cleared
Jun 21, 2012
AXERA ACCESS SYSTEM
Cardiovascular
29d
Cleared
Nov 09, 2011
AXERA ACCESS SYSTEM
Cardiovascular
20d
Cleared
May 24, 2011
ARSTASIS DILATOR ADAPTER
Cardiovascular
183d
Cleared
Feb 02, 2011
ARSTASIS ONE LATCHWIRE ACCESS SYSTEM
Cardiovascular
100d
Cleared
Oct 07, 2010
ARSTASIS ACCESS SYSTEM
Cardiovascular
15d