FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NMI PORT
K Number: K122767
·
Decision Apr 30, 2013
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
287
Applicant Total
35
Review Days
232
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Basic Information
- Device Name
- NMI PORT
- K Number
- K122767
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Navilyst Medical, Inc.
- Date Received
- September 10, 2012
- Decision Date
- April 30, 2013
- 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 Navilyst Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K163452 | PICC Maximal Barrier Nursing Kit | Feb 3, 2017 | Unknown |
| K161866 | BioFlo Midline Catheter | Sep 8, 2016 | Substantially Equivalent |
| K151239 | NMI DUAL PORT II | Jun 6, 2016 | Substantially Equivalent |
| K153228 | NMI Port, NMI Port II | Dec 4, 2015 | Substantially Equivalent |
| K152409 | Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC | Sep 24, 2015 | Substantially Equivalent |
| K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter | Sep 24, 2015 | Substantially Equivalent |
| K150407 | BioFlo Midline Catheter | May 15, 2015 | Substantially Equivalent |
| K150527 | Xcela Power Injectable PICC | Mar 31, 2015 | Substantially Equivalent |
| K150448 | NMI PICC III and NMI PICC IV | Mar 19, 2015 | Substantially Equivalent |
| K142616 | PICC Maximal Barrier Nursing Kit | Oct 14, 2014 | Substantially Equivalent |