NMI PORT II CATHETER
FDA 510(k) clearance K131694 · decided 2013-08-08
Clearance details
- K-number
- K131694
- Device name
- NMI PORT II CATHETER
- Applicant
- Navilyst Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-06-10
- Decision date
- 2013-08-08
- Days to decision
- 59 days
- Clearance type
- Abbreviated
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Pro recall (Z-0826-2014) | Navilyst Medical, Inc. | 2014-01-24 |