K171483 is an FDA 510(k) clearance for the ArchFlo CT Midline. This device is classified as a Midline Catheter (Class II - Special Controls, product code PND).
Submitted by Medcomp (Dba Medical Components, Inc.) (Harleysville, US). The FDA issued a Cleared decision on December 15, 2017, 207 days after receiving the submission on May 22, 2017.
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 | K171483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2017 |
| Decision Date | December 15, 2017 |
| Days to Decision | 207 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. |