K200891 is an FDA 510(k) clearance for the BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System. 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 (Sandy, US). The FDA issued a Cleared decision on June 2, 2021, 425 days after receiving the submission on April 3, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K200891 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2020 |
| Decision Date | June 02, 2021 |
| Days to Decision | 425 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 |