FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDRAD INTEGO PET INFUSION SYSTEM
K Number: K080297
·
Decision Jun 17, 2008
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
105
Review Days
134
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Basic Information
- Device Name
- MEDRAD INTEGO PET INFUSION SYSTEM
- K Number
- K080297
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medrad, Inc.
- Date Received
- February 4, 2008
- Decision Date
- June 17, 2008
- Product Code
- FRN
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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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 |
| 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 |