NMI PICC III CATHETER, NMI HPICC III CATHETER— 510(k) K131942
Substantially EquivalentNavilyst Medical, Inc.
FDA 510(k) clearance K131942 for NMI PICC III CATHETER, NMI HPICC III CATHETER, Substantially Equivalent on 2013-07-31. Applicant: Navilyst Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Navilyst Medical, Inc.
- Product code
- Product code LJS
- Device class
- Class 2
- Regulation
- 21 CFR 880.5970
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marlborough, MA, US
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More clearances from Navilyst Medical, Inc.
view allAdverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
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.