The following data is part of a premarket notification filed by Becton Dickinson Vascular Access, Inc. with the FDA for Safedwel(r) Central Venous Catheter.
| Device ID | K914528 |
| 510k Number | K914528 |
| Device Name: | SAFEDWEL(R) CENTRAL VENOUS CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Contact | Welle |
| Correspondent | Welle BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-09 |
| Decision Date | 1992-10-13 |