FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
K Number: K080813
·
Decision Jul 1, 2008
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
63
Applicant Total
24
Review Days
102
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Basic Information
- Device Name
- PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
- K Number
- K080813
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2870
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radi Medical Systems AB
- Date Received
- March 21, 2008
- Decision Date
- July 1, 2008
- Product Code
- DXO
- 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 |
|---|---|---|---|
| DXO | Transducer, Pressure, Catheter Tip | FDA class 2 | Cardiovascular |
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|---|---|---|---|
| K123984 | QUANTIEN MEASUREMENT SYSTEM | Mar 28, 2013 | Substantially Equivalent |
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| K080206 | MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM | Feb 26, 2008 | Substantially Equivalent |
| K062769 | PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 | Dec 4, 2006 | Substantially Equivalent |
| K042628 | MODIFICATION TO: RADIANALYZER, MODEL 12711 | Jan 19, 2005 | Substantially Equivalent |
| K033291 | TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 | Mar 17, 2004 | Substantially Equivalent |
| K031662 | PRESSURE WIRE SENSOR, MODELS 12004/12304 | Jun 6, 2003 | Substantially Equivalent |
| K024107 | FEMOSTOP FEMORAL COMPRESSION SYSTEM | Dec 24, 2002 | Substantially Equivalent |
| K022188 | RADIANALYZER, MODEL 12710 | Oct 3, 2002 | Substantially Equivalent |
| K022187 | PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 | Sep 24, 2002 | Substantially Equivalent |