The following data is part of a premarket notification filed by Becton Dickinson Vascular Access, Inc. with the FDA for Deseret(r) I.v. Loop And Deseret (r) J Loop.
| Device ID | K950303 |
| 510k Number | K950303 |
| Device Name: | DESERET(R) I.V. LOOP AND DESERET (R) J LOOP |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-25 |
| Decision Date | 1995-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903851213 | K950303 | 000 |
| 50382903851206 | K950303 | 000 |