FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OCCLUSION BALLOON CATHETER, MODEL VENOS
K Number: K081052
·
Decision Jun 18, 2008
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
98
Applicant Total
49
Review Days
65
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Basic Information
- Device Name
- OCCLUSION BALLOON CATHETER, MODEL VENOS
- K Number
- K081052
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Oscor, Inc.
- Date Received
- April 14, 2008
- Decision Date
- June 18, 2008
- Product Code
- DYG
- 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 |
|---|---|---|---|
| DYG | Catheter, Flow Directed | FDA class 2 | Cardiovascular |
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