FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO
K Number: K001237
·
Decision May 18, 2000
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
89
Applicant Total
51
Review Days
30
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Basic Information
- Device Name
- EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO
- K Number
- K001237
- 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
- April 18, 2000
- Decision Date
- May 18, 2000
- 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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