The following data is part of a premarket notification filed by Becton Dickinson Vascular Access, Inc. with the FDA for Insyte, Insyte-w, Insyte Autoguard Catheters.
| Device ID | K971339 |
| 510k Number | K971339 |
| Device Name: | INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Contact | C.j. Welle |
| Correspondent | C.j. Welle BECTON DICKINSON VASCULAR ACCESS, 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 | 1997-04-10 |
| Decision Date | 1997-12-24 |
| Summary: | summary |