FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
NMI DIALYSIS CATHETER
K Number: K131260
·
Decision Feb 14, 2014
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
123
Applicant Total
35
Review Days
288
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Basic Information
- Device Name
- NMI DIALYSIS CATHETER
- K Number
- K131260
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Navilyst Medical, Inc.
- Date Received
- May 2, 2013
- Decision Date
- February 14, 2014
- Product Code
- MSD
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| MSD | Catheter, Hemodialysis, Implanted | FDA class 2 | Gastroenterology, Urology |
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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 |