FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIDA PTV DILATATON CATHETER
K Number: K131002
·
Decision Jul 2, 2013
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
4
Applicant Total
645
Review Days
83
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Basic Information
- Device Name
- VIDA PTV DILATATON CATHETER
- K Number
- K131002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C.R. Bard, Inc.
- Date Received
- April 10, 2013
- Decision Date
- July 2, 2013
- Product Code
- OMZ
- 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 |
|---|---|---|---|
| OMZ | Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OMZ), ordered by most recent decision date.
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NUMED COEFFICIENT PTV CATHETERS
FDA 510(k)
FDA Class 2
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