FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER
K Number: K112513
·
Decision Dec 9, 2011
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
11
Review Days
101
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Basic Information
- Device Name
- EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER
- K Number
- K112513
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Natec Medical , Ltd.
- Date Received
- August 30, 2011
- Decision Date
- December 9, 2011
- Product Code
- LIT
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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| K112735 | TAMARIN BLUE PTCA RX DILATATION CATHETER | Nov 2, 2012 | Substantially Equivalent |
| K103354 | EBONY PTA .035 PERIPHERAL DILATATION CATHETER | Feb 23, 2011 | Substantially Equivalent |