K213203 is an FDA 510(k) clearance for the Provena(TM) Midline Catheter. This device is classified as a Midline Catheter (Class II - Special Controls, product code PND).
Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on May 13, 2022, 226 days after receiving the submission on September 29, 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 | K213203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2021 |
| Decision Date | May 13, 2022 |
| Days to Decision | 226 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. |