The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Angiocath Autoguard Catheter, Insyte Autoguard Catheter.
| Device ID | K984059 |
| 510k Number | K984059 |
| Device Name: | ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 9450 SOUTH STATE SREET Sandy, UT 84070 |
| Contact | Charles J Welle |
| Correspondent | Charles J Welle BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 9450 SOUTH STATE SREET 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 | 1998-11-13 |
| Decision Date | 1999-04-09 |
| Summary: | summary |