The following data is part of a premarket notification filed by B. Braun Interventional Systems Inc. with the FDA for Celsite Implantable Access Port Systems.
| Device ID | K130576 |
| 510k Number | K130576 |
| Device Name: | CELSITE IMPLANTABLE ACCESS PORT SYSTEMS |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | B. BRAUN INTERVENTIONAL SYSTEMS INC. 3100 W Lake St Ste 420 Minneapolis, MN 55416 |
| Contact | Amber Kingston |
| Correspondent | Amber Kingston B. BRAUN INTERVENTIONAL SYSTEMS INC. 3100 W Lake St Ste 420 Minneapolis, MN 55416 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-05 |
| Decision Date | 2013-04-02 |
| Summary: | summary |