The following data is part of a premarket notification filed by Becton Dickinson Infusion Therapy Systems Inc. with the FDA for Bd Intima Ii Closed Iv Catheter.
| Device ID | K143610 |
| 510k Number | K143610 |
| Device Name: | BD INTIMA II CLOSED 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 | John Roberts |
| Correspondent | John Roberts 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 | 2014-12-19 |
| Decision Date | 2015-04-09 |
| Summary: | summary |