FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXERA 2 ACCESS SYSTEM
K Number: K132263
·
Decision Aug 19, 2013
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
14
Review Days
28
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Basic Information
- Device Name
- AXERA 2 ACCESS SYSTEM
- K Number
- K132263
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arstasis, Inc.
- Date Received
- July 22, 2013
- Decision Date
- August 19, 2013
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Arstasis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151877 | MicroTract Access System | Aug 7, 2015 | Substantially Equivalent |
| K140871 | AXERA 2 ACCESS SYSTEM | Jun 6, 2014 | Substantially Equivalent |
| K140287 | AXERA RX ACCESS SYSTEM | May 16, 2014 | Substantially Equivalent |
| K140201 | AXERA 2 ACCESS SYSTEM | Mar 28, 2014 | Substantially Equivalent |
| K123618 | AXERA 2 ACCESS SYSTEM | Mar 24, 2013 | Substantially Equivalent |
| K123135 | AXERA 2 ACCESS SYSTEM MODEL AXE200 | Jan 28, 2013 | Substantially Equivalent |
| K121521 | AXERA ACCESS SYSTEM | Jun 21, 2012 | Substantially Equivalent |
| K113110 | AXERA ACCESS SYSTEM | Nov 9, 2011 | Substantially Equivalent |
| K103421 | ARSTASIS DILATOR ADAPTER | May 24, 2011 | Substantially Equivalent |
| K103143 | ARSTASIS ONE LATCHWIRE ACCESS SYSTEM | Feb 2, 2011 | Substantially Equivalent |