Submission Details
| 510(k) Number | K213203 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
Provena(TM) Midline Catheter
May 2022
Decision
226d
Days
Class 2
Risk
About This 510(k) Submission
K213203 is an FDA 510(k) clearance for the Provena(TM) Midline Catheter, 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 review panel. Regulated under 21 CFR 880.5200.
Device Classification
| 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. |
Manufacturer
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