NMI DUAL PORT II— 510(k) K151239
Substantially EquivalentNavilyst Medical, Inc.
FDA 510(k) clearance K151239 for NMI DUAL PORT II, Substantially Equivalent on 2016-06-06. Applicant: Navilyst Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Navilyst Medical, Inc.
- Product code
- Code LJT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5965
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
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More clearances from Navilyst Medical, Inc.
view all- K163452 — PICC Maximal Barrier Nursing Kit
- K161866 — BioFlo Midline Catheter
- K153228 — NMI Port, NMI Port II
- K152069 — Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter
- K152409 — Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
Adverse events under product code LJT
product code LJT- Death
- 234
- Injury
- 6,468
- Malfunction
- 5,326
- Other
- 2
- Total
- 12,030
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.