FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT
K Number: K092486
·
Decision Aug 28, 2009
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
20
Applicant Total
3
Review Days
15
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Basic Information
- Device Name
- VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT
- K Number
- K092486
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4390
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vortex Medical, Inc.
- Date Received
- August 13, 2009
- Decision Date
- August 28, 2009
- Product Code
- DWE
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DWE | Tubing, Pump, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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