FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
K Number: K082382
·
Decision Dec 12, 2008
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
91
Applicant Total
34
Review Days
115
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Basic Information
- Device Name
- ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
- K Number
- K082382
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Possis Medical, Inc.
- Date Received
- August 19, 2008
- Decision Date
- December 12, 2008
- Product Code
- QEZ
- 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 |
|---|---|---|---|
| QEZ | Aspiration Thrombectomy Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Possis Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133629 | ANGIOJET ULTRA AVX THROMBECTOMY SET | Feb 14, 2014 | Substantially Equivalent |
| K091593 | ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS | Jun 22, 2009 | Substantially Equivalent |
| K090253 | ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001 | Apr 8, 2009 | Substantially Equivalent |
| K081989 | MODIFICATION TO FETCH ASPIRATION CATHETER | Sep 26, 2008 | Substantially Equivalent |
| K081454 | GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE | Jun 13, 2008 | Substantially Equivalent |
| K080806 | ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 | Apr 4, 2008 | Substantially Equivalent |
| K073441 | ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 | Jan 24, 2008 | Substantially Equivalent |
| K072769 | ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS | Nov 14, 2007 | Substantially Equivalent |
| K072269 | ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552 | Sep 8, 2007 | Substantially Equivalent |
| K071336 | ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 | Aug 24, 2007 | Substantially Equivalent |