FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
K Number: K011656
·
Decision Jun 20, 2001
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
89
Applicant Total
51
Review Days
22
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Basic Information
- Device Name
- HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
- K Number
- K011656
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micro Therapeutics, Inc.
- Date Received
- May 29, 2001
- Decision Date
- June 20, 2001
- Product Code
- MJN
- 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 |
|---|---|---|---|
| MJN | Catheter, Intravascular Occluding, Temporary | FDA class 2 | Cardiovascular |
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