K200266 is an FDA 510(k) clearance for the BD Centro Vena Acute Central Line (7 French Dual Lumen). This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Bard Access Systems, Inc. (Bard Has Joined Bd) (Salt Lake Ciy,, US). The FDA issued a Cleared decision on April 7, 2020, 64 days after receiving the submission on February 3, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K200266 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2020 |
| Decision Date | April 07, 2020 |
| Days to Decision | 64 days |
| Submission Type | Special |
| 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 |