The following data is part of a premarket notification filed by Becton Dickinson Infusion Therapy Systems, Inc. with the FDA for Insyte Catheter, Insyte Autoguard Catheter.
| Device ID | K000235 |
| 510k Number | K000235 |
| Device Name: | INSYTE CATHETER, INSYTE AUTOGUARD CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Contact | Leslie Wood |
| Correspondent | Leslie Wood BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. 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 | 2000-01-27 |
| Decision Date | 2000-04-05 |