The following data is part of a premarket notification filed by Becton, Dickinson Infusion Therapy Systems, Inc. with the FDA for Bd Cathena (tm) Safety Iv Catheter.
| Device ID | K192493 |
| 510k Number | K192493 |
| Device Name: | BD Cathena (TM) Safety IV Catheter |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | Becton, Dickinson Infusion Therapy Systems, Inc. 9450 South State Street Sandy, UT 84070 |
| Contact | Henry Boland |
| Correspondent | Henry Boland Becton, Dickinson Infusion Therapy Systems, Inc. 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 | 2019-09-11 |
| Decision Date | 2020-01-24 |