The following data is part of a premarket notification filed by Bard Access Systems, Inc. with the FDA for Vascular Access Catheter Accessories.
| Device ID | K935380 |
| 510k Number | K935380 |
| Device Name: | VASCULAR ACCESS CATHETER ACCESSORIES |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR. Salt Lake City, UT 84116 |
| Contact | Jane A Martin |
| Correspondent | Jane A Martin BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR. Salt Lake City, UT 84116 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-08 |
| Decision Date | 1995-02-17 |