FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS
K Number: K081472
·
Decision Sep 23, 2008
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
287
Applicant Total
87
Review Days
119
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Basic Information
- Device Name
- SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS
- K Number
- K081472
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AngioDynamics, Inc.
- Date Received
- May 27, 2008
- Decision Date
- September 23, 2008
- Product Code
- LJT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | FDA class 2 | General Hospital |
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