The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Celsite/ Celsite Concept, Access Ports.
| Device ID | K061424 |
| 510k Number | K061424 |
| Device Name: | CELSITE/ CELSITE CONCEPT, ACCESS PORTS |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Lisa Boyle |
| Correspondent | Lisa Boyle AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-23 |
| Decision Date | 2006-07-31 |
| Summary: | summary |