The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Intima Ii Closed Iv Catheter System, Bd Intima Ii Plus Closed Iv Catheter System.
| Device ID | K200891 |
| 510k Number | K200891 |
| Device Name: | BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | Becton, Dickinson And Company 9450 South State Street Sandy, UT 84070 |
| Contact | Kimberly Geisler |
| Correspondent | Kimberly Geisler Becton, Dickinson And Company 9450 South State Street Sandy, UT 84070 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-03 |
| Decision Date | 2021-06-02 |