FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDRAD OMNIPLANE 300 SYSTEM
K Number: K883834
·
Decision Nov 4, 1988
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
105
Review Days
56
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Basic Information
- Device Name
- MEDRAD OMNIPLANE 300 SYSTEM
- K Number
- K883834
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Medrad, Inc.
- Date Received
- September 9, 1988
- Decision Date
- November 4, 1988
- Product Code
- KPR
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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Other Clearances by Medrad, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K113428 | ANGIOJET ULTRA DVX THROMBECTOMY SET | Dec 2, 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 |