FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT
K Number: K870187
·
Decision May 7, 1987
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
287
Applicant Total
20
Review Days
111
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Basic Information
- Device Name
- NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT
- K Number
- K870187
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Norfolk Medical Products, Inc.
- Date Received
- January 16, 1987
- Decision Date
- May 7, 1987
- 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 Norfolk Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K192291 | TidalPort-AP Implantable Apheresis Vascular Access Port | Aug 20, 2020 | Substantially Equivalent |
| K112713 | NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS | Oct 27, 2011 | Substantially Equivalent |
| K102385 | NORFOLK MEDICAL NORPORT FAMILY OF PORTS | Jan 14, 2011 | Substantially Equivalent |
| K942784 | NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED | May 2, 1995 | Substantially Equivalent |
| K896544 | MD2 PERSONAL INFUSION SYSTEM | May 2, 1990 | Substantially Equivalent |
| K872838 | NORFOLK NORPORT (TM) -SP (SKIN PARALLEL) | Aug 25, 1987 | Substantially Equivalent |
| K871209 | NORFOLK MEDICAL NORPORT | Jun 24, 1987 | Substantially Equivalent |
| K871192 | SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT | Jun 10, 1987 | Substantially Equivalent |
| K870519 | SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT | Apr 15, 1987 | Substantially Equivalent |
| K870188 | NORFOLK MEDICAL BUTTERFLY INFUSION SET | Feb 10, 1987 | Substantially Equivalent |