Arstasis, Inc.
United StatesFDA applicant, unverified
- Devices
- 14
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Arstasis, Inc. makes
Arstasis, Inc. manufactures vascular access systems, including wire-based access tools (e.g., the Arstasis One LatchWire Access System) and dilator adapters designed for medical procedures. Their portfolio includes multiple iterations of the Axera Access System, tailored for specific clinical applications, as well as the ITG Vascular Access System (Model 300) and the Axera RX Access System.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. These products are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the United States.
Catalogue
Search and filter all 14 devicesFDA recalls
FDA recall records list 1 recall initiated by Arstasis, Inc., initiated on 2010-10-19. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2010
- 19 Oct 2010 Z-0993-2011 Unclassified (pre-2012) Terminated Device has the potential to fracture and sheath separation during use.
Frequently asked questions
How many devices does Arstasis, Inc. have in the registry?
The registry currently lists 14 devices for Arstasis, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Arstasis, Inc.'s devices?
Among its 14 most recently registered devices, Arstasis, Inc. has devices listed in FDA 510(k) (14 devices).
What risk classes do Arstasis, Inc.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Arstasis, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Arstasis, Inc.?
FDA recall records list 1 recall initiated by Arstasis, Inc., the most recent initiated on 2010-10-19. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Arstasis, Inc. in the registry?
The most recently registered devices listed for Arstasis, Inc. include ARSTASIS ONE LATCHWIRE ACCESS SYSTEM, AXERA ACCESS SYSTEM, ARSTASIS DILATOR ADAPTER and AXERA 2 ACCESS SYSTEM.