FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)
K Number: K070003
·
Decision May 15, 2007
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
287
Applicant Total
40
Review Days
132
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Basic Information
- Device Name
- POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)
- K Number
- K070003
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medcomp
- Date Received
- January 3, 2007
- Decision Date
- May 15, 2007
- 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 Medcomp
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|---|---|---|---|
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| K091466 | 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 | Jun 17, 2009 | Substantially Equivalent |
| K081775 | THE MEDCOMP .010 VASCULAR GUIDEWIRES | Mar 25, 2009 | Substantially Equivalent |