FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM
K Number: K133569
·
Decision Dec 20, 2013
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
21
Applicant Total
34
Review Days
30
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Basic Information
- Device Name
- TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM
- K Number
- K133569
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1255
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bard Peripheral Vascular, Inc.
- Date Received
- November 20, 2013
- Decision Date
- December 20, 2013
- Product Code
- OZT
- 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 |
|---|---|---|---|
| OZT | Balloon Aortic Valvuloplasty | FDA class 2 | Cardiovascular |
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INOUE BALLOON A
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