K213855 is an FDA 510(k) clearance for the Arrow Pressure Injectable Midline Catheter. This device is classified as a Midline Catheter (Class II - Special Controls, product code PND).
Submitted by Arrow International, LLC Subsidiary of Teleflex Incorporated (Morrisville, US). The FDA issued a Cleared decision on September 2, 2022, 266 days after receiving the submission on December 10, 2021.
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 | K213855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2021 |
| Decision Date | September 02, 2022 |
| Days to Decision | 266 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. |