The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Vaxcel With Pasv Port, Model 45-213.
| Device ID | K032008 |
| 510k Number | K032008 |
| Device Name: | VAXCEL WITH PASV PORT, MODEL 45-213 |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Contact | Jodi Lynn Greenizen |
| Correspondent | Jodi Lynn Greenizen BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-30 |
| Decision Date | 2003-07-14 |
| Summary: | summary |