Medical Device Manufacturer · US , San Carlos , CA

Arstasis, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2010

Recent clearances: MicroTract Access System, AXERA 2 ACCESS SYSTEM, AXERA RX ACCESS SYSTEM

View 14 510(k) Devices ↓
14
Total
14
Cleared
0
Denied

FDA 510(k) Regulatory Record - Arstasis, Inc. Cardiovascular ✕

14 devices
1-12 of 14
Cleared Aug 07, 2015
MicroTract Access System
K151877 · DRE
Cardiovascular · 29d
Cleared Jun 06, 2014
AXERA 2 ACCESS SYSTEM
K140871 · DYB
Cardiovascular · 63d
Cleared May 16, 2014
AXERA RX ACCESS SYSTEM
K140287 · DYB
Cardiovascular · 100d
Cleared Mar 28, 2014
AXERA 2 ACCESS SYSTEM
K140201 · DYB
Cardiovascular · 60d
Cleared Aug 19, 2013
AXERA 2 ACCESS SYSTEM
K132263 · DYB
Cardiovascular · 28d
Cleared Mar 24, 2013
AXERA 2 ACCESS SYSTEM
K123618 · DYB
Cardiovascular · 121d
Cleared CT Jan 28, 2013
AXERA 2 ACCESS SYSTEM MODEL AXE200
K123135 · DYB
Cardiovascular · 115d
Cleared Jun 21, 2012
AXERA ACCESS SYSTEM
K121521 · DYB
Cardiovascular · 29d
Cleared Nov 09, 2011
AXERA ACCESS SYSTEM
K113110 · DYB
Cardiovascular · 20d
Cleared May 24, 2011
ARSTASIS DILATOR ADAPTER
K103421 · DRE
Cardiovascular · 183d
Cleared Feb 02, 2011
ARSTASIS ONE LATCHWIRE ACCESS SYSTEM
K103143 · DYB
Cardiovascular · 100d
Cleared Oct 07, 2010
ARSTASIS ACCESS SYSTEM
K102728 · DYB
Cardiovascular · 15d
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