Submission Details
| 510(k) Number | K251155 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 14, 2025 |
| Decision Date | July 11, 2025 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
K251155 is an FDA 510(k) clearance for the BD Cathena? Safety IV Catheter, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on July 11, 2025, 88 days after receiving the submission on April 14, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K251155 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 14, 2025 |
| Decision Date | July 11, 2025 |
| Days to Decision | 88 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 |