K210264 is an FDA 510(k) clearance for the BD PowerPiCC Catheter. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Bard Access Systems, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on July 30, 2021, 179 days after receiving the submission on February 1, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K210264 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2021 |
| Decision Date | July 30, 2021 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |