K210047 is an FDA 510(k) clearance for the Stiletto Extended Dwell Catheter. This device is classified as a Midline Catheter (Class II - Special Controls, product code PND).
Submitted by Piper Access, LLC (Salt Lake City, US). The FDA issued a Cleared decision on August 27, 2021, 231 days after receiving the submission on January 8, 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 | K210047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2021 |
| Decision Date | August 27, 2021 |
| Days to Decision | 231 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. |