Arstasis, Inc.
San Carlos, CA, US
Arstasis, Inc. appears in FDA device records in San Carlos, CA. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Arstasis, Inc. between 2010 and 2015. The busiest year on record is 2010, with 3. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 1 |
| 2013 | 3 |
| 2014 | 3 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K151877 | MicroTract Access System | DRE | Substantially Equivalent | |
| K140871 | AXERA 2 ACCESS SYSTEM | DYB | Substantially Equivalent | |
| K140287 | AXERA RX ACCESS SYSTEM | DYB | Substantially Equivalent | |
| K140201 | AXERA 2 ACCESS SYSTEM | DYB | Substantially Equivalent | |
| K132263 | AXERA 2 ACCESS SYSTEM | DYB | Substantially Equivalent | |
| K123618 | AXERA 2 ACCESS SYSTEM | DYB | Substantially Equivalent | |
| K123135 | AXERA 2 ACCESS SYSTEM MODEL AXE200 | DYB | Substantially Equivalent | |
| K121521 | AXERA ACCESS SYSTEM | DYB | Substantially Equivalent | |
| K113110 | AXERA ACCESS SYSTEM | DYB | Substantially Equivalent | |
| K103421 | ARSTASIS DILATOR ADAPTER | DRE | Substantially Equivalent | |
| K103143 | ARSTASIS ONE LATCHWIRE ACCESS SYSTEM | DYB | Substantially Equivalent | |
| K102728 | ARSTASIS ACCESS SYSTEM | DYB | Substantially Equivalent | |
| K100615 | ARSTASIS ACCESS SYSTEM | DYB | Substantially Equivalent | |
| K091006 | ITG VASCULAR ACCESS SYSTEM, MODEL 300 | DYB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0993-2011 | Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of the following components: (1) Device Sheath/Anchor, (2) Shaft and (3) Handle with control features. Product is manufactured and distributed by Arstasis Inc., San Carlos, CA The Arstasis One Access System is a sterile, single use system intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The System is Indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using SF or 6F Introducer sheaths. | Device has the potential to fracture and sheath separation during use. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Arstasis, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain