K181208 is an FDA 510(k) clearance for the Vygon Midline 3 Fr SL Catheter. This device is classified as a Midline Catheter (Class II - Special Controls, product code PND).
Submitted by Vygon USA (Lansdale, US). The FDA issued a Cleared decision on November 2, 2018, 179 days after receiving the submission on May 7, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200. The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days..
| 510(k) Number | K181208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2018 |
| Decision Date | November 02, 2018 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PND - Midline Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |
| Definition | The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days. |