K192802 is an FDA 510(k) clearance for the primeMidline Catheters. This device is classified as a Midline Catheter (Class II - Special Controls, product code PND).
Submitted by Pfm Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 28, 2019, 28 days after receiving the submission on September 30, 2019.
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 | K192802 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2019 |
| Decision Date | October 28, 2019 |
| Days to Decision | 28 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. |