The following data is part of a premarket notification filed by B. Braun Of America, Inc. with the FDA for Celsite(tm) Dual Venous System.
| Device ID | K945551 |
| 510k Number | K945551 |
| Device Name: | CELSITE(TM) DUAL VENOUS SYSTEM |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | B. BRAUN OF AMERICA, INC. 824 TWELFTH AVE. PO BOX 4027 Bethlehem, PA 18018 -0027 |
| Contact | Mark S Alsberge |
| Correspondent | Mark S Alsberge B. BRAUN OF AMERICA, INC. 824 TWELFTH AVE. PO BOX 4027 Bethlehem, PA 18018 -0027 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-04-21 |