FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
NORFOLK MEDICAL PERITONEAL-ACCESS PORT
K Number: K854593
·
Decision Feb 4, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
20
Review Days
78
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Basic Information
- Device Name
- NORFOLK MEDICAL PERITONEAL-ACCESS PORT
- K Number
- K854593
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Norfolk Medical Products, Inc.
- Date Received
- November 18, 1985
- Decision Date
- February 4, 1986
- Product Code
- LMQ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LMQ | Device, Peritoneal Access, Subcutaneous, Implanted | FDA class 3 | Unknown |
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 |
| K870187 | NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT | May 7, 1987 | Substantially Equivalent |
| K870519 | SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT | Apr 15, 1987 | Substantially Equivalent |