FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VORTEX ACCESS SYSTEM
K Number: K010189
·
Decision Feb 12, 2001
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
287
Applicant Total
16
Review Days
21
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Basic Information
- Device Name
- VORTEX ACCESS SYSTEM
- K Number
- K010189
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Horizon Medical Products, Inc.
- Date Received
- January 22, 2001
- Decision Date
- February 12, 2001
- 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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Other Clearances by Horizon Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K033473 | MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT | Nov 18, 2003 | Substantially Equivalent |
| K032754 | VORTEX MP | Sep 12, 2003 | Substantially Equivalent |
| K032557 | TRIUMPH VTX WITH LIFEVALVE CATHETER | Sep 9, 2003 | Substantially Equivalent |
| K031718 | LIFEVALVE CENTRAL VENOUS CATHTER | Jul 2, 2003 | Substantially Equivalent |
| K022905 | LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER | Dec 13, 2002 | Substantially Equivalent |
| K013871 | LIFEGUARD SAFETY INFUSION SET | Mar 29, 2002 | Substantially Equivalent |
| K011916 | SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES | Oct 31, 2001 | Substantially Equivalent |
| K010767 | LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES | Apr 10, 2001 | Substantially Equivalent |
| K994196 | HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM | Feb 10, 2000 | Substantially Equivalent |
| K951814 | TRIUMPH-1 PORT | Aug 29, 1995 | Substantially Equivalent |