FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANGIOJET ULTRA DVX THROMBECTOMY SET
K Number: K113428
·
Decision Dec 2, 2011
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
91
Applicant Total
105
Review Days
11
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ANGIOJET ULTRA DVX THROMBECTOMY SET
- K Number
- K113428
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medrad, Inc.
- Date Received
- November 21, 2011
- Decision Date
- December 2, 2011
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QEZ), ordered by most recent decision date.
Liberant RX Aspiration Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
FLOWRUNNER Aspiration System
FDA 510(k)
FDA Class 2
·Cardiovascular
Aventus Thrombectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
AlphaVac Multipurpose Mechanical Aspiration System F1885
FDA 510(k)
FDA Class 2
·Cardiovascular
Vesalio Peripheral System
FDA 510(k)
FDA Class 2
·Cardiovascular
FLOWRUNNER Aspiration System
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Medrad, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133023 | JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 | Aug 27, 2014 | Substantially Equivalent |
| K130381 | ANGIOJET ULTRA POWER PULSE KIT | Jul 29, 2013 | Substantially Equivalent |
| K130637 | JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM | Apr 10, 2013 | Substantially Equivalent |
| K122916 | JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM | Oct 19, 2012 | Substantially Equivalent |
| K113363 | ANGIOJET SOLENT DISTA THROMBECTOMY SET | Jun 6, 2012 | Substantially Equivalent |
| K113133 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE | Dec 15, 2011 | Substantially Equivalent |
| K112086 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE | Oct 14, 2011 | Substantially Equivalent |
| K111182 | ANGIOJET SOLENT OMNI THROMBECTOMY SET | May 24, 2011 | Substantially Equivalent |
| K100798 | MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C | Jun 23, 2010 | Substantially Equivalent |
| K082905 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC | Jan 12, 2009 | Substantially Equivalent |