K170770 is an FDA 510(k) clearance for the CT Midline. This device is classified as a Midline Catheter (Class II - Special Controls, product code PND).
Submitted by Medical Components, Inc. (dba MedComp) (Harleysville, US). The FDA issued a Cleared decision on July 25, 2017, 133 days after receiving the submission on March 14, 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 | K170770 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2017 |
| Decision Date | July 25, 2017 |
| Days to Decision | 133 days |
| Submission Type | Special |
| 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. |