K190855 is an FDA 510(k) clearance for the BD Acute Central Line. 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 November 1, 2019, 213 days after receiving the submission on April 2, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K190855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2019 |
| Decision Date | November 01, 2019 |
| Days to Decision | 213 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 |