FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ENDOWAVE INFUSION SYSTEM
K Number: K073166
·
Decision Apr 22, 2008
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
174
Applicant Total
23
Review Days
165
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Basic Information
- Device Name
- ENDOWAVE INFUSION SYSTEM
- K Number
- K073166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Ekos Corp.
- Date Received
- November 9, 2007
- Decision Date
- April 22, 2008
- Product Code
- KRA
- 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 |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | FDA class 2 | Cardiovascular |
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Other Clearances by Ekos Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K081467 | EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION | Jun 26, 2008 | Substantially Equivalent |
| K080392 | EndoWave Infusion System | Apr 30, 2008 | Substantially Equivalent |
| K072507 | ENDOWAVE INFUSION SYSTEM | Oct 4, 2007 | Substantially Equivalent |
| K071933 | ENDOWAVE INFUSION SYSTEM | Aug 10, 2007 | Substantially Equivalent |
| K063620 | EKOS MICRO-INFUSION SYSTEM | Aug 6, 2007 | Unknown |
| K062508 | NEUROWAVE MICRO-INFUSION SYSTEM | Dec 5, 2006 | Unknown |
| K062507 | MICRO-INFUSION SYSTEM | Nov 22, 2006 | Substantially Equivalent |
| K060422 | LYSUS INFUSION SYSTEM | Mar 9, 2006 | Substantially Equivalent |
| K060084 | LYSUS INFUSION SYSTEM | Feb 7, 2006 | Substantially Equivalent |
| K053437 | EKOS MICRO-INFUSION SYSTEM | Jan 6, 2006 | Substantially Equivalent |