The following data is part of a premarket notification filed by Becton Dickinson Infusion Therapy Systems Inc. with the FDA for Bd Cathena Safety Iv Catheter.
| Device ID | K201717 |
| 510k Number | K201717 |
| Device Name: | BD Cathena 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 | Paul Holman |
| Correspondent | Paul Holman 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-23 |
| Decision Date | 2020-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382903868897 | K201717 | 000 |
| 50382903868709 | K201717 | 000 |
| 30382903868699 | K201717 | 000 |
| 50382903868686 | K201717 | 000 |
| 50382903868679 | K201717 | 000 |
| 50382903868655 | K201717 | 000 |
| 30382903868644 | K201717 | 000 |
| 50382903868631 | K201717 | 000 |
| 50382903868624 | K201717 | 000 |
| 50382903868617 | K201717 | 000 |
| 30382903868798 | K201717 | 000 |
| 30382903868804 | K201717 | 000 |
| 30382903868842 | K201717 | 000 |
| 50382903868914 | K201717 | 000 |
| 50382903868907 | K201717 | 000 |
| 50382903868877 | K201717 | 000 |
| 30382903868835 | K201717 | 000 |
| 30382903868828 | K201717 | 000 |
| 30382903868811 | K201717 | 000 |
| 30382903868590 | K201717 | 000 |
| 50382903868860 | K201717 | 000 |
| 30382903868859 | K201717 | 000 |
| 50382903868600 | K201717 | 000 |