K240359 is an FDA 510(k) clearance for the PowerGlide Pro™ Midline Catheter. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Becton, Dickinson and Company (Bard Access Systems, Inc.) (Salt Lake City, US). The FDA issued a Cleared decision on July 29, 2024, 174 days after receiving the submission on February 6, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K240359 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2024 |
| Decision Date | July 29, 2024 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |