FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MicroTract Access System
K Number: K151877
·
Decision Aug 7, 2015
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
14
Review Days
29
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Basic Information
- Device Name
- MicroTract Access System
- K Number
- K151877
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arstasis, Inc.
- Date Received
- July 9, 2015
- Decision Date
- August 7, 2015
- Product Code
- DRE
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
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Other Clearances by Arstasis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K132263 | AXERA 2 ACCESS SYSTEM | Aug 19, 2013 | 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 |